Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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)
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.
Secondary ID [1] 303676 0
n/a
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
end-of-life care 321073 0
Palliative Care 321313 0
COVID-19 321536 0
Condition category
Condition code
Public Health 319100 319100 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 320108 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326987 0
The study will explore how participants experience the transition from hospital to RACF with palliative care needs as described in semi-structured qualitative interviews.



Timepoint [1] 326987 0
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.
Primary outcome [2] 327166 0
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.
Timepoint [2] 327166 0
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.
Primary outcome [3] 327167 0
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.
Timepoint [3] 327167 0
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.
Secondary outcome [1] 393360 0
None
Timepoint [1] 393360 0
None

Eligibility
Key inclusion criteria
Patient received palliative care intervention provided by RaPIC while residing in an aged care facility.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patient or family psychosocial risk factors precluding safe participation in qualitative research
Legal guardianship of patients

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/05/2021
Actual
Date of last participant enrolment
Anticipated
1/10/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18890 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 33396 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 308095 0
Hospital
Name [1] 308095 0
Monash Health
Country [1] 308095 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Monash Health Foundation
Address
Monash Medical Centre Clayton
246 Clayton road
Clayton, VIC, 3168
Country
Australia
Secondary sponsor category [1] 309012 0
None
Name [1] 309012 0
Address [1] 309012 0
Country [1] 309012 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308081 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 308081 0
Monash Medical Centre Clayton
246 Clayton road
Clayton, VIC, 3168
Ethics committee country [1] 308081 0
Australia
Date submitted for ethics approval [1] 308081 0
22/03/2021
Approval date [1] 308081 0
06/05/2021
Ethics approval number [1] 308081 0
RES- 20-0000-687A

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109466 0
A/Prof Peter Poon
Address 109466 0
McCulloch House
Monash Medical Centre Clayton
246 Clayton road
Clayton, Vic, 3168
Country 109466 0
Australia
Phone 109466 0
+61 3 95945347
Fax 109466 0
Email 109466 0
poon@iinet.net.au
Contact person for public queries
Name 109467 0
A/Prof Peter Poon
Address 109467 0
McCulloch House
Monash Medical Centre Clayton
246 Clayton road
Clayton, Vic, 3168
Country 109467 0
Australia
Phone 109467 0
+61 3 95945347
Fax 109467 0
Email 109467 0
ppoon@iinet.net.au
Contact person for scientific queries
Name 109468 0
A/Prof Peter Poon
Address 109468 0
McCulloch House
Monash Medical Centre Clayton
246 Clayton road
Clayton, Vic, 3168
Country 109468 0
Australia
Phone 109468 0
+61 3 95945347
Fax 109468 0
Email 109468 0
ppoon@iinet.net.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11002Ethical approvalPlease contact Associate Professor Peter Poon regarding supporting documents.  ppoon@iinet.net.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.