ANZCTR - Registration

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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]

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

Condition category

Condition code

Neurological

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]

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]

Proportion of deaths in hospital in persons with dementia.

Timepoint [1]

Time of death from up to 12 months post enrolment

Secondary outcome [1]

Number of ED attendances by the persons with dementia, determined by electronic health record, confirmed with carer interview

Timepoint [1]

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

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Fiona Stanley Hospital - Murdoch

Recruitment postcode(s) [1]

6150 - Murdoch

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Research Translation Project Round 12 of WA Health

Address [1]

189 Royal St, Perth WA 6004

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Metropolitan Health Service Human Research Ethics Committee

Ethics committee address [1]

HREC Executive Officer
Post: PO Box 8172
Perth Business Centre
Perth WA 6849

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/11/2018

Approval date [1]

12/02/2019

Ethics approval number [1]

Summary

Brief summary

Whist palliative care is highly effective for patients with dementia and their carers it is rarely accessed. We hypothesize that the provision of education, advance care planning and better referral to palliative care for carers will reduce the number of people with dementia that die in hospital and result in improvements in systems and patients centered outcomes. Therefore, this research is about increasing access to palliative care for a group of patients that are currently underrepresented.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Glenn Arendts

Address

University of Western Australia, 35 Stirling Hwy, Crawley WA 6009.

Fiona Stanley Hospital, 11 Robin Warren Dr, Murdoch WA 6150

Country

Australia

Phone

+61 08 61511227

Fax

[email protected]

Contact person for public queries

Name

Glenn Arendts

Address

University of Western Australia, 35 Stirling Hwy, Crawley WA 6009.

Fiona Stanley Hospital, 11 Robin Warren Dr, Murdoch WA 6150

Country

Australia

Phone

+61 08 61511227

Fax

[email protected]

Contact person for scientific queries

Name

Glenn Arendts

Address

University of Western Australia, 35 Stirling Hwy, Crawley WA 6009.

Fiona Stanley Hospital, 11 Robin Warren Dr, Murdoch WA 6150

Country

Australia

Phone

+61 08 61511227

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
3096	Study protocol			[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Caring for persons with Dementia: a qualitative study of the needs of carers following care recipient discharge from hospital.	2023	https://dx.doi.org/10.1186/s12904-023-01322-1

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically