Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001187134
Ethics application status
Approved
Date submitted
16/07/2019
Date registered
26/08/2019
Date last updated
20/02/2023
Date data sharing statement initially provided
26/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised trial of a Carer End of Life Planning Intervention (CELPI) in people dying with dementia.
Scientific title
A randomised trial of a Carer End of Life Planning Intervention (CELPI) and its effect on the proportion of people with dementia dying in hospital
Secondary ID [1] 298741 0
Nil known
Universal Trial Number (UTN)
U1111-1237-0223
Trial acronym
CELPI Program
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Support for carers of people living with advanced stage dementia

 313672 0
Condition category
Condition code
Neurological 312085 312085 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To test whether an intervention triad of carer education, end of life planning and palliative care reduces the proportion of recipients dying in hospital. CELPI is the acronym for the name of the study: Carer End of Life Planning Intervention. The CELPI Carer Directed Needs Assessment is a self-designed assessment that will be used during the intervention phase of this study to assist carers to develop a care plan to meet their current and future care needs as well as those of their care recipient.
An intervention will be implemented after the baseline assessments have been conducted by the Recruiter (Research Nurse) and the participants have been randomized to either the control group or the intervention group. The Intervention Clinician will receive an electronic notification of those participants assigned to the intervention group along with a PDF of patient admission data from the Recruiter. Upon receipt of the email, the Intervention Clinician will contact the participant (carer) to make a single appointment to meet them in their homes or at a location of their choice at a time that is convenient to them. The length of the visit is expected to be between 1.5 - 2 hours long. Each participant will receive a single visit. Subsequent visits may be required but are not mandated. During the 1.5 - 2 hours visit:
1. A self-designed assessment- the CELPI Carer Directed Needs Assessment (CCDNA) will be used to establish the carers perception of their care recipient’s current and future needs as well as their own. No assessments will be conducted on the care recipient (patient) or the carer.
2. Within the CCDNA is the carer-reported Symptom Assessment Scale (SAS). Use of the SAS will establish whether or not there have been any changes since the baseline assessment was conducted. The carer will report on their perception of their care recipient’s current status. Should the rating score indicate a palliative care referral is required, the clinician will discuss whether the carer wants a referral to be made, the process of referral to Silverchain and then contact the Silverchain Palliative Care Nurse Practitioner for her immediate response.
3. The carer will be educated on the use of SAS so that he/she can monitor their care recipient daily.
4. The CCDNA contains questions pertaining to the carer's understanding of dementia, the stages of dementia, the process of dying and whether or not they want to know more about it. Issues regarding equipment needs, advance care planning, finances, social support and in-home palliative care vs aged care facility admission will also be discussed.
5. The clinician will ensure the carer understands the referral process, who to call in an emergency and have the resources (i.e. contact numbers) of service providers such as The Independent Living Centre, Continence Management, Carers WA, Silverchain, Palliative Care WA and Alzheimer’s WA to draw upon as required. Participants will also be given the Palliative Caring- Information for families and carers who are caring for a person with a life-limiting illness or condition provided by Palliative Care Western Australia. This booklet discusses all aspects of care and provides resources for carers to draw on.
5. A collaborative care plan will be documented.
Should a carer express concern about their care recipient who is palliative and who resides in a residential aged care facility, the referral will be made to the Metropolitan Palliative Care Consultancy Services.
The Intervention Clinician is an early career researcher and occupational therapist.
Intervention code [1] 315007 0
Treatment: Other
Comparator / control treatment
The control group will be given an information brochure about dementia that lists contact numbers of services providers. This brochure is specifically designed for this study.
Control group
Active

Outcomes
Primary outcome [1] 320731 0
Proportion of deaths in hospital in persons with dementia.
Timepoint [1] 320731 0
Time of death from up to 12 months post enrolment
Secondary outcome [1] 372640 0
Number of ED attendances by the persons with dementia, determined by electronic health record, confirmed with carer interview
Timepoint [1] 372640 0
Count of number of ED attendances for 12 months post enrolment or until death.

Eligibility
Key inclusion criteria
Inclusion criteria for carer participants:
• Patient must present to the ED, ESSU or MDAC ward with dementia, delirium or both. Delirium is not a contraindication as long as severe dementia can be established at baseline
• Patient has past medical history of dementia or a discharge letter confirming their diagnosis
• Patient is 65 years old or older
• Established diagnosis of dementia, confirmed MMSE < 13/30 (or equivalent when MMSE is not an appropriate assessment) in ED
• Identified as having a life expectancy of less than 12 months, operationalise as FAST scale 6d- 7e (doubling incontinent or loss of ability to speak more than 6 words, unable to stand, unable to sit upright, unable to smile.
• Medicare eligible
• Carer must know the person has dementia
• Patient is living in the community or in residential aged care.
• The carer must reside within 30km travel distance of the enrolling ED.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for carer participants:
• No identifiable primary carer or surrogate decision maker
• Death is considered imminent (within 72 hours)
• Insufficient English to provide informed consent
• Prior palliative care team support
• Significant symptoms (e.g. pain, dyspnoea) requiring a referral to specialist palliative care on this presentation.
• No access to a telephone, or a hearing disability that prevents use of a telephone
• A place of residence >30KMs from the Fiona Stanley Hospital

Study design
Purpose of the study
Prevention
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)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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 200 participants which will provide sufficient power to detect reduction in the primary outcome (proportion of patients dying in hospital) from 35% to 20% with significance level of 0.05.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
26/08/2019
Actual
26/08/2019
Date of last participant enrolment
Anticipated
30/04/2022
Actual
30/04/2022
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
200
Accrual to date
Final
63
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 14227 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 27220 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 303298 0
Government body
Name [1] 303298 0
Research Translation Project Round 12 of WA Health
Country [1] 303298 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Glenn Arendts
Address
University of Western Australia
35 Stirling Hwy, Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 303319 0
None
Name [1] 303319 0
Address [1] 303319 0
Country [1] 303319 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303829 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 303829 0
Ethics committee country [1] 303829 0
Australia
Date submitted for ethics approval [1] 303829 0
22/11/2018
Approval date [1] 303829 0
12/02/2019
Ethics approval number [1] 303829 0

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

Contacts
Principal investigator
Name 94958 0
A/Prof Glenn Arendts
Address 94958 0
University of Western Australia, 35 Stirling Hwy, Crawley WA 6009.

Fiona Stanley Hospital, 11 Robin Warren Dr, Murdoch WA 6150
Country 94958 0
Australia
Phone 94958 0
+61 08 61511227
Fax 94958 0
Email 94958 0
glenn.arendts@uwa.edu.au
Contact person for public queries
Name 94959 0
Glenn Arendts
Address 94959 0
University of Western Australia, 35 Stirling Hwy, Crawley WA 6009.

Fiona Stanley Hospital, 11 Robin Warren Dr, Murdoch WA 6150
Country 94959 0
Australia
Phone 94959 0
+61 08 61511227
Fax 94959 0
Email 94959 0
glenn.arendts@uwa.edu.au
Contact person for scientific queries
Name 94960 0
Glenn Arendts
Address 94960 0
University of Western Australia, 35 Stirling Hwy, Crawley WA 6009.

Fiona Stanley Hospital, 11 Robin Warren Dr, Murdoch WA 6150
Country 94960 0
Australia
Phone 94960 0
+61 08 61511227
Fax 94960 0
Email 94960 0
glenn.arendts@uwa.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
Any information will be used solely for the research relating to this application and will not be shared.


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  glenn.arendts@uwa.edu.au


Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCaring for persons with Dementia: a qualitative study of the needs of carers following care recipient discharge from hospital.2023https://dx.doi.org/10.1186/s12904-023-01322-1
N.B. These documents automatically identified may not have been verified by the study sponsor.