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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12621000565842
Ethics application status
Approved
Date submitted
30/03/2021
Date registered
13/05/2021
Date last updated
13/05/2021
Date data sharing statement initially provided
13/05/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Rapid Palliative Care In-Reach for COVID-19 (RaPIC)
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Scientific title
Understanding the lived experience of Rapid Palliative care In-reach for COVID-19 (RaPIC): views of aged care facility residents and their families.
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Secondary ID [1]
303676
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n/a
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
end-of-life care
321073
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Palliative Care
321313
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COVID-19
321536
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Condition category
Condition code
Public Health
319100
319100
0
0
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Other public health
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
The RaPIC program is provided through the RAPID team, a multidisciplinary palliative care team that looks to provide gap-fill palliative care interventions upon discharge to a residential care facility. This includes medical, nursing and psychosocial care.
Participants have access to RaPIC as it is a pre-existing service. The recruitment will be purposive sampling targeting residents and families who have received support through the service.
Participants will take part in a semi-structured qualitative interview. Following participation in the interview encounter, participants will be offered and provided follow-up support for any unmet concerns or needs relating to their health care. Any information of concerns that arise during the period of follow-up care will not be part of data collection.
From a qualitative perspective, the focus of the interviews will consider how awareness of the COVID-19 pandemic's impact on the aged care system influences participants perceptions of palliative and end-of-life care in aged care facilities. In the event, that there is further community transmission, the qualitative interview will consider the unique needs of COVID-19 positive residents and their families.
The interviews will be completed by a research social worker, conducted face to face, via telephone or video conferencing depending on participant preference. The duration of the interview will vary depending on participant comfort, and the depth and scope of information participants are willing to share. We estimate the interviews will take between 30 minutes to 2 hours.
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Intervention code [1]
320108
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The study will explore how participants experience the transition from hospital to RACF with palliative care needs as described in semi-structured qualitative interviews.
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Assessment method [1]
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Timepoint [1]
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Residential aged care residents and their families will be invited to participate in an interview one week following discharge from service for aged care residents and their families.
OR
Bereaved relatives of deceased aged care residents and clients of RaPIC will be approached one month following the death of the care recipient.
The timepoint for data collection and interview will be negotiated with potential participants depending on their personal circumstances, taking in to account the presence of grief and/or distress, and needs following a death such as funerals and other related practical requirements.
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Primary outcome [2]
327166
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This study will consider how the COVID-19 pandemic has influenced perceptions of palliative care provision in residential aged care facilities as described in semi-structured qualitative interviews.
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Assessment method [2]
327166
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Timepoint [2]
327166
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Residential aged care residents and their families will be invited to participate in an interview one week following discharge from service for aged care residents and their families.
OR
Bereaved relatives of deceased aged care residents and clients of RaPIC will be approached one month following the death of the care recipient.
The timepoint for data collection and interview will be negotiated with potential participants depending on their personal circumstances, taking in to account the presence of grief and/or distress, and needs following a death such as funerals and other related practical requirements.
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Primary outcome [3]
327167
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This study will examine how the RaPIC program facilitates good quality palliative care in RACF from the perspective of residents and their families as described in semi-structured qualitative interviews.
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Assessment method [3]
327167
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Timepoint [3]
327167
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Residential aged care residents and their families will be invited to participate in an interview one week following discharge from service for aged care residents and their families.
OR
Bereaved relatives of deceased aged care residents and clients of RaPIC will be approached one month following the death of the care recipient.
The timepoint for data collection and interview will be negotiated with potential participants depending on their personal circumstances, taking in to account the presence of grief and/or distress, and needs following a death such as funerals and other related practical requirements.
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Secondary outcome [1]
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None
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Assessment method [1]
393360
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Timepoint [1]
393360
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None
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Eligibility
Key inclusion criteria
Patient received palliative care intervention provided by RaPIC while residing in an aged care facility.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Patient or family psychosocial risk factors precluding safe participation in qualitative research
Legal guardianship of patients
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Study design
Purpose
Psychosocial
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
This CTR refers specifically to the qualitative sub-study of a review of this novel service.
Qualitative Outcomes
Semi-structured interviews will be conducted by telephone or videoconference with professional transcription.
Sample size: 20 participants depending on theoretical sampling.
Data will be analysed using an interpretive phenomenological analytical framework.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
18/05/2021
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Actual
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Date of last participant enrolment
Anticipated
1/10/2021
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Actual
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Date of last data collection
Anticipated
31/12/2021
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
18890
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Monash Medical Centre - Clayton campus - Clayton
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Recruitment postcode(s) [1]
33396
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3168 - Clayton
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Funding & Sponsors
Funding source category [1]
308095
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Hospital
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Name [1]
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Monash Health
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Address [1]
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Monash Medical Centre Clayton
246 Clayton road
Clayton, VIC, 3168
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Country [1]
308095
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
Monash Health Foundation
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Address
Monash Medical Centre Clayton
246 Clayton road
Clayton, VIC, 3168
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Country
Australia
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Secondary sponsor category [1]
309012
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None
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Name [1]
309012
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Address [1]
309012
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Country [1]
309012
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
308081
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Monash Health Human Research Ethics Committee
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Ethics committee address [1]
308081
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Monash Medical Centre Clayton
246 Clayton road
Clayton, VIC, 3168
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Ethics committee country [1]
308081
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Australia
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Date submitted for ethics approval [1]
308081
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22/03/2021
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Approval date [1]
308081
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06/05/2021
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Ethics approval number [1]
308081
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RES- 20-0000-687A
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Summary
Brief summary
Brief Description
The COVID-19 pandemic highlights the urgent supportive and palliative care (PC) needs and deficiencies in this unprecedented health crisis. In Victoria, the greatest impact has been felt in the vulnerable aged care sector. Access to specialist PC for symptom and end-of-life care has been inadequate. The research model proposed allows for multiple access points to PC services independent of illness trajectory, location or point of integration to other care providers, facilitated by telehealth to allow rapid and responsive delivery. It is well suited to address the urgent aged care COVID-19 PC needs.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Peter Poon
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Address
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McCulloch House
Monash Medical Centre Clayton
246 Clayton road
Clayton, Vic, 3168
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Country
109466
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Australia
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Phone
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+61 3 95945347
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Fax
109466
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Email
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[email protected]
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Contact person for public queries
Name
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A/Prof Peter Poon
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Address
109467
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McCulloch House
Monash Medical Centre Clayton
246 Clayton road
Clayton, Vic, 3168
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Country
109467
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Australia
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Phone
109467
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+61 3 95945347
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Fax
109467
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Email
109467
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Peter Poon
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Address
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McCulloch House
Monash Medical Centre Clayton
246 Clayton road
Clayton, Vic, 3168
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Country
109468
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Australia
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Phone
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+61 3 95945347
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Fax
109468
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Email
109468
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
11002
Ethical approval
Please contact Associate Professor Peter Poon regarding supporting documents.
[email protected]
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.
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