Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001357741
Ethics application status
Approved
Date submitted
12/10/2022
Date registered
21/10/2022
Date last updated
21/10/2022
Date data sharing statement initially provided
21/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of VAD on Palliative Care
Scientific title
The Impact of Voluntary Assisted Dying (VAD) on the Quality of Palliative Care Delivered by Palliative Care Services with a Conscientious Objection
Secondary ID [1] 308134 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Palliative Care 327464 0
Voluntary Assisted Dying 327963 0
End of life care 327964 0
Condition category
Condition code
Public Health 324595 324595 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 study aims to explore the means by which services continue to deliver palliative care and care for the bereaved considering the ethical, legal and clinical implications in the context of the new legislations, Voluntary Assisted Dying (VAD) which has been passed in all states in Australia. The main objectives of the study is to:
1) assess the clinical decisions associated with the provision of VAD and the overall care delivered to these patients.
2) examine the impact of VAD on care providers, palliative care teams, family and carers, including evidence for moral distress, ethical challenges, and complicated grief in bereavement.
3) examine whether the possibility of VAD has had an impact on the understanding of ‘outcomes’ or ‘quality’ of palliative care among care providers, palliative care teams, family and carers.
4) identify specific issues pertaining to legislation and its operations that compromise our ability to maintain ethical integrity and seek ways to mitigate these issues.
The cohort consists of those patients who have enquired or accessed the VAD process after June 2019. The caregivers and health practitioners who provided care for this cohort of patients will also be eligible. The study will involve the review of 100-120 patient medical records and interviews with 20-30 patients, 20-30 caregivers, 20-30 bereaved caregivers and 20-30 health practitioners. This study will be conducted across eight sites in Victoria and Western Australia. After the qualitative and quantitative data is collected there will not be any follow up or further observations on this cohort of people.
Information from patient medical records will include: demographics, diagnosis, health service utilisation, reason and date of death. The medical record will be accessed from the time of expression of interest in VAD until last contact with health services or patient time of death. The interviews will be conducted once for 15-30 minutes either face-to-face or online with a semi-structured interview conducted by a trained project officer.
Intervention code [1] 324589 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332739 0
Health service utilisation will be assessed by reviewing the patient medical records and identifying referrals, hospital admission, length of stay and emergency department presentations.
Timepoint [1] 332739 0
Review of medical records from first to last contact with health services or patient time of death
Primary outcome [2] 332740 0
Palliative Care Outcomes Collaboration (PCOC) measures will be assessed as a composite primary outcome and will be obtained from the medical records.
Timepoint [2] 332740 0
All PCOC measures completed in the patient medical records from initial assessment to any subsequent assessments completed.
Primary outcome [3] 332743 0
Outcome of VAD request
Outcome will be assessed from the patient medical records
Timepoint [3] 332743 0
Last patient record or time of death
Secondary outcome [1] 414590 0
Health Practitioner identified issues will be identified during the semi-structured interview which will include a question exploring the challenges faced when providing end of life care. These interviews will be conducted by a trained project officer.
Timepoint [1] 414590 0
At time of enrolment an interview will be conducted. Issues may be identified in medical records. Issues maybe identified in medical records collated from June 2019 to end of study enrolment period.
Secondary outcome [2] 414591 0
Patient identified issues at time of 15-30 minute semi-structure interview conducted by a trained project officer which explores the challenges faced by the patient.
Timepoint [2] 414591 0
Identified at time of patient interview at time of enrolment.
Secondary outcome [3] 414592 0
Place of death will be identified in medical records.
Timepoint [3] 414592 0
Time of death
Secondary outcome [4] 414865 0
Caregiver raised issues at time of 15-30 minute semi-structure interview conducted by a trained project officer which explores the challenges faced by the caregiver.
Timepoint [4] 414865 0
Identified at time of caregiver interview at time of enrolment.

Eligibility
Key inclusion criteria
Patients who have expressed an interest in or explicitly sought VAD from 19th June 2019 onwards will be identified at each service.
Those eligible will include those who have considered VAD and engaged in discussions about its potential use and those who have engaged in the VAD process and who have or have not died using VAD.
Caregivers and health practitioners involved in an eligible patient's care will also be eligible to participate in this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Ineligible patients will be those who made a fleeting reference to VAD but did not engage in more detailed discussions. These patient's caregivers and the health practitioners who provided care will be ineligible to participate in this study.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Descriptive statistics on quantitative data; Transcription of qualitative data, entry into N-Vivo, qualitative content analysis program.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2022
Actual
Date of last participant enrolment
Anticipated
3/04/2023
Actual
Date of last data collection
Anticipated
28/04/2023
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA,VIC
Recruitment hospital [1] 23339 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [2] 23340 0
St John of God Hospital, Murdoch - Murdoch
Recruitment hospital [3] 23341 0
St John of God Hospital, Midland - Midland
Recruitment hospital [4] 23342 0
Werribee Mercy Hospital - Werribee
Recruitment hospital [5] 23344 0
Cabrini Hospital - Prahran - Prahran East
Recruitment hospital [6] 23345 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [7] 23348 0
Wantirna Health - Wantirna
Recruitment hospital [8] 23349 0
Calvary Health Care Bethlehem Ltd - Caulfield
Recruitment hospital [9] 23386 0
Villa Maria Catholic Homes (VMCH) - East Melbourne
Recruitment postcode(s) [1] 38784 0
3002 - East Melbourne
Recruitment postcode(s) [2] 38717 0
3030 - Werribee
Recruitment postcode(s) [3] 38720 0
3065 - Fitzroy
Recruitment postcode(s) [4] 38723 0
3152 - Wantirna
Recruitment postcode(s) [5] 38724 0
3162 - Caulfield
Recruitment postcode(s) [6] 38719 0
3181 - Prahran East
Recruitment postcode(s) [7] 38712 0
6008 - Subiaco
Recruitment postcode(s) [8] 38716 0
6056 - Midland
Recruitment postcode(s) [9] 38713 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 312130 0
Other Collaborative groups
Name [1] 312130 0
Archdiocese of Sydney
Country [1] 312130 0
Australia
Funding source category [2] 312392 0
Other Collaborative groups
Name [2] 312392 0
St Vincent's Health Australia
Country [2] 312392 0
Australia
Funding source category [3] 312393 0
Other Collaborative groups
Name [3] 312393 0
Mercy Health
Country [3] 312393 0
Australia
Funding source category [4] 312394 0
Other Collaborative groups
Name [4] 312394 0
Villa Maria Catholic Homes
Country [4] 312394 0
Australia
Funding source category [5] 312395 0
Other Collaborative groups
Name [5] 312395 0
Cabrini Health
Country [5] 312395 0
Australia
Funding source category [6] 312396 0
Other Collaborative groups
Name [6] 312396 0
St John of God Health Care
Country [6] 312396 0
Australia
Primary sponsor type
University
Name
University of Notre Dame
Address
128-140 Broadway,
Chippendale NSW 2007
Country
Australia
Secondary sponsor category [1] 313650 0
None
Name [1] 313650 0
Address [1] 313650 0
Country [1] 313650 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311525 0
Mercy Health HREC
Ethics committee address [1] 311525 0
Mercy Hospitals Victoria Ltd
Level 2, 12 Shelley Street
Richmond Vic 3121
Ethics committee country [1] 311525 0
Australia
Date submitted for ethics approval [1] 311525 0
10/03/2022
Approval date [1] 311525 0
01/06/2022
Ethics approval number [1] 311525 0
2022-008
Ethics committee name [2] 311748 0
Calvary Health Care Bethlehem HREC
Ethics committee address [2] 311748 0
152 Como Parade West,
Parkdale VIC 3195
Ethics committee country [2] 311748 0
Australia
Date submitted for ethics approval [2] 311748 0
20/07/2022
Approval date [2] 311748 0
20/09/2022
Ethics approval number [2] 311748 0
22081801
Ethics committee name [3] 311749 0
Cabrini Research Governance Office
Ethics committee address [3] 311749 0
Level 2, 154 Wattletree Rd
MALVERN VIC 3144
Ethics committee country [3] 311749 0
Australia
Date submitted for ethics approval [3] 311749 0
30/06/2022
Approval date [3] 311749 0
04/08/2022
Ethics approval number [3] 311749 0
01-04-08-22
Ethics committee name [4] 311750 0
Villa Maria Catholic Homes Governance
Ethics committee address [4] 311750 0
486 Albert St
East Melbourne
Vic 3002
Ethics committee country [4] 311750 0
Australia
Date submitted for ethics approval [4] 311750 0
10/06/2022
Approval date [4] 311750 0
03/08/2022
Ethics approval number [4] 311750 0
2022:001

Summary
Brief summary
Over the first three years of the Voluntary Assisted Dying (VAD) legislation, patients, families and clinicians have experienced significant challenges as they seek information, access and a better understanding of the ethical, legal and clinical implications of VAD. Several anecdotal accounts have been shared across services, but no systematic effort has been undertaken to study the in-depth impact of this legislation.
We propose applying several lenses which include a clinical, ethical, psycho-existential focus on: patients, caregivers, health practitioners, and services-as-a-whole. We have assembled an experienced team of palliative and psychosocial care providers, ethicists and service leaders to undertake this review. The setting examines the unique interaction where the legal directive of VAD does not clearly align with the ethical and clinical principles of health care delivery in end of life care and palliative care.
By sustaining our focus on the quality-of-care provision to patients and families, this research is not driven by polemics. Instead, its focus is on clinical outcomes that embrace both patients and families and care providers and enables an in-depth analysis of this new model of care to be undertaken. The goal is directed towards optimising palliative care, not the delivery of VAD. The potential for moral distress, impact on care provision and unwelcome bereavement outcomes make this focus of study worthwhile and necessary to sustain the model of palliative care delivery.
A mixed-methods approach will be employed using qualitative and quantitative methodology and case reviews. We will retrospectively assess socio-demographic, medical and health utilisation data from the medical records of patients (n=120) who have expressed an interest in or pursued VAD, specifically identifying pertinent clinical issues and the utilisation of palliative care services. A qualitative descriptive approach will be used to analyse interviews (n=120) undertaken with clinicians and family caregivers about their experiences of the VAD process, involvement of palliative care and bereavement support.
In addition to thematic analysis, the researchers will use these data to construct anonymised case studies that illustrate or exemplify ethical issues or challenges. These will be shared with expert bioethics collaborators who will comment on the issues themselves and on the potential usefulness of case studies, perhaps modified, for the purposes of medical education.
Ultimately this information will be valuable to inform policy, future legislation, education and support for our community around end of life care and palliative care provision.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121406 0
A/Prof Natasha Michael
Address 121406 0
Cabrini Health
646 High St
Prahran
Vic 3181
Country 121406 0
Australia
Phone 121406 0
+61400966376
Fax 121406 0
Email 121406 0
nmichael@cabrini.com.au
Contact person for public queries
Name 121407 0
A/Prof Natasha Michael
Address 121407 0
Cabrini Health
646 High St
Prahran
Vic 3181
Country 121407 0
Australia
Phone 121407 0
+61 3 95085027
Fax 121407 0
Email 121407 0
nmichael@cabrini.com.au
Contact person for scientific queries
Name 121408 0
A/Prof Natasha Michael
Address 121408 0
Cabrini Health
646 High St
Prahran
Vic 3181
Country 121408 0
Australia
Phone 121408 0
+61 3 95085027
Fax 121408 0
Email 121408 0
nmichael@cabrini.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not be available or shared. As this is a small sample size there is a risk of identification of individuals so only grouped data will be available in publications and reports.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17295Study protocol  nmichael@cabrini.com.au
17296Statistical analysis plan  nmichael@cabrini.com.au
17297Informed consent form  nmichael@cabrini.com.au
17298Clinical study report  nmichael@cabrini.com.au
17299Ethical approval  nmichael@cabrini.com.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.