Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000611729
Ethics application status
Approved
Date submitted
4/04/2022
Date registered
22/04/2022
Date last updated
30/11/2023
Date data sharing statement initially provided
22/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
CELPI: a randomised trial of a Carer End of Life Planning Intervention in people dying with dementia.
Scientific title
CELPI: a randomised trial evaluating the effect of a Carer End of Life Planning Intervention in people dying with dementia.
Secondary ID [1] 305711 0
Nil known
Universal Trial Number (UTN)
U1111-1271-0600
Trial acronym
CELPI Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Support for carers of people living with advanced stage dementia 324178 0
Condition category
Condition code
Neurological 321652 321652 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a Carer End of Life Planning Intervention (CELPI) triad comprised of carer education, end of life planning and specialist palliative care referral. A carer needs assessment (CANDID) was designed for the trial, will be conducted by a non-physician member of the research team and provides a holistic needs assessment which will direct the CELPI components. CANDID captures information on the current and future needs of both the carer and the person with dementia, as well as clarifying what, if any, advance care planning has been done to date. The CANDID assessment is conducted through a face to face interview over 1-2 hours, following which a bespoke CELPI for that carer will be developed and documented incorporating a summary of needs and a plan to address these using available resources. This includes current needs; likely future complications; and if necessary, training the carer in the use of symptom scales that can be used to guide carer-initiated treatments for distressing symptoms. A management plan for changed behaviours is incorporated into the intervention. The specialist palliative care referral component during follow up will address key details of;
i) what a palliative care referral would entail
ii) what a palliative approach and advance care planning looks like for a person dying with dementia.
The assessment will be used to develop and implement tailored follow up actions by an agreed referral plan to address these needs mapped to existing available services and will offer access to these services (delivered via community or hospital) to align care with patient wishes for how they would want their end of life to be. CANDID will capture any prior advance health directive or care plan made by the person with dementia when they had capacity, as well as any prior goals of care discussions already held with the carer.
The intervention will be delivered in the participants home by the Intervention Clinician, a non-physician member of the research team, and there will be follow up with a phone call by the clinician 4 weeks post CELPI delivery to confirm the currency and completeness of the plan.
Intervention code [1] 322094 0
Treatment: Other
Comparator / control treatment
The control group will be given an information brochure about palliative care in dementia that lists contact numbers of services providers in each participating state. This brochure is specifically designed for this study. Otherwise they will receive standard care with no CANDID assessment or CELPI.
Control group
Active

Outcomes
Primary outcome [1] 329433 0
Proportion of people with dementia dying at their preferred location, as communicated by the person or their carer. The carer will nominate this at baseline assessment by phone or in person.
Timepoint [1] 329433 0
Time of death from up to 12 months post enrolment
Secondary outcome [1] 402596 0
1. Proxy (carer) reported quality of life of the person with dementia using Quality of Life in Late-Stage Dementia (QUALID)
Timepoint [1] 402596 0
1. Measured every three months up to 12 months via telephone contact with participant-carer, unless death intervenes,
Secondary outcome [2] 408483 0
2. Carer stress using Modified Caregiver Strain Index (MCSI)
Timepoint [2] 408483 0
2. Measured every three months up to 12 months via telephone contact with participant-carer, unless death intervenes
Secondary outcome [3] 408484 0
3. Carer quality of life using EQ5D-5L
Timepoint [3] 408484 0
3. Measured every three months up to 12 months via telephone contact with participant-carer, unless death intervenes,
Secondary outcome [4] 408485 0
4. Number of ED attendances post enrolment (with and without subsequent admission to hospital)
Timepoint [4] 408485 0
4. Count of number of ED attendances by the persons with dementia, determined by electronic health record, confirmed via telephone contact with participant-carer. If confirmed with participant-carer, assessed every three months up to 12 months unless death intervenes.
Secondary outcome [5] 408486 0
5. Hospital occupied bed days
Timepoint [5] 408486 0
5. Count of number of hospital attendances by the persons with dementia, determined by electronic health record, confirmed via telephone contact with participant-carer. If confirmed with participant-carer, assessed every three months up to 12 months unless death intervenes.
Secondary outcome [6] 408487 0
6. Days spent by person with dementia in nominated preferred location of care post enrolment
Timepoint [6] 408487 0
6. Calculated to time of death from up to 12 months post enrolment, confirmed via telephone contact with participant-carer
Secondary outcome [7] 408488 0
7. Number and type of medical interventions in last seven days of life
Timepoint [7] 408488 0
7. Determined by electronic health record, confirmed via telephone contact with participant-carer
Secondary outcome [8] 408489 0
8. If the person with dementia dies in the follow up period, bereavement risk in the carer using the Modified Bereavement Risk Index (MRBI)
Timepoint [8] 408489 0
8. Measured at first follow up post death of the person with dementia via telephone contact with participant-carer

Eligibility
Key inclusion criteria
Screening and enrolment will be conducted during or after an ED visit. The study population is the primary identified carer of a person with dementia attending a participating ED who meets the following criteria:

1. Age is greater than or equal to 65 years
2. Established documented diagnosis of dementia, confirmed with MMSE <13/30 (or equivalent when MMSE is not an appropriate assessment) in ED
3. Identified as having a life expectancy of less than 12 months, operationalised as FAST scale 6d-7e (doubly incontinent or loss ability to speak more than 6 words, unable to stand, unable to sit upright, unable to smile)
4. Medicare eligible

Furthermore, the carer must reside within a 30km travel distance of the enrolling ED or be able to use a telehealth option.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. No identifiable carer as a surrogate medical decision maker
2. Person with dementia is under the care of the Public Guardian
3. Death is considered imminent (within one week)
4. Person with dementia is a current patient of a specialist palliative care service, or a prior patient within the preceding 12 months
5. Significant symptoms (eg. pain, dyspnoea) requiring a referral to specialist palliative care on this presentation
6. Carer requires translation of written and spoken language

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We anticipate recruiting 440 participants which will provide sufficient power (90%) to detect a 15% increase in the proportion of people dying in preferred locations to 75% with significance level of 0.05. The overall difference in proportion of participants dying in a preferred location between the intervention and control groups will be assessed using logistic regression. Secondary outcome analyses of quality of life and strain measures, collected multiple times from the same patient-carer dyad, will be performed by constructing random effects models with the intervention group variable interacted with time to account for within-dyad correlation. Health system outcomes will be assessed by including the intervention group variable in an appropriate count-based regression model that accounts for the variable exposure (length of time before death). Inclusion of baseline data in regression models will be used to explore additional variation within dyad characteristics.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/05/2022
Actual
14/11/2022
Date of last participant enrolment
Anticipated
30/04/2024
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
440
Accrual to date
97
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC
Recruitment hospital [1] 21014 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 21015 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [3] 21016 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [4] 21017 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [5] 21018 0
St George Hospital - Kogarah
Recruitment hospital [6] 21019 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 35849 0
6150 - Murdoch
Recruitment postcode(s) [2] 35850 0
6009 - Nedlands
Recruitment postcode(s) [3] 35851 0
3050 - Parkville
Recruitment postcode(s) [4] 35852 0
3084 - Heidelberg
Recruitment postcode(s) [5] 35853 0
2217 - Kogarah
Recruitment postcode(s) [6] 35854 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 310069 0
Government body
Name [1] 310069 0
The National Health and Medical Research Council (NHMRC)
Country [1] 310069 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
35 Stirling Hwy, Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 311121 0
None
Name [1] 311121 0
Address [1] 311121 0
Country [1] 311121 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309761 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 309761 0
Ethics committee country [1] 309761 0
Australia
Date submitted for ethics approval [1] 309761 0
25/11/2021
Approval date [1] 309761 0
13/01/2022
Ethics approval number [1] 309761 0
RGS0000001373

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

Contacts
Principal investigator
Name 115298 0
A/Prof Glenn Arendts
Address 115298 0
The University of Western Australia
35 Stirling Hwy, Crawley WA 6009
Country 115298 0
Australia
Phone 115298 0
+61 08 6457 4354
Fax 115298 0
Email 115298 0
[email protected]
Contact person for public queries
Name 115299 0
Glenn Arendts
Address 115299 0
The University of Western Australia
35 Stirling Hwy, Crawley WA 6009
Country 115299 0
Australia
Phone 115299 0
+61 08 6457 4354
Fax 115299 0
Email 115299 0
[email protected]
Contact person for scientific queries
Name 115300 0
Glenn Arendts
Address 115300 0
The University of Western Australia
35 Stirling Hwy, Crawley WA 6009
Country 115300 0
Australia
Phone 115300 0
+61 08 6457 4354
Fax 115300 0
Email 115300 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual data collected during the trial; after de-identification
When will data be available (start and end dates)?
Beginning 3 months and ending 7 years following main results publication
Available to whom?
Researchers who provide a methodologically sound proposal
Available for what types of analyses?
Meta analyses
How or where can data be obtained?
Access subject to approval by Principal Investigator or proxy.
Contact: [email protected] or [email protected]


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
No additional documents have been identified.