Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001164886
Ethics application status
Approved
Date submitted
31/10/2012
Date registered
2/11/2012
Date last updated
12/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving Dementia end of life care at local aged care facilities.
Scientific title
Cluster randomised controlled trial of facilitated case conferencing versus usual care for improving end of life outcomes in aged care residents with advanced dementia and their families.
Secondary ID [1] 281051 0
nil
Universal Trial Number (UTN)
U1111-1136-2430
Trial acronym
IDEAL Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced dementia 287191 0
Condition category
Condition code
Neurological 287520 287520 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be implemented over 18 months.

We will use a train-the-trainer model, whereby a paid Palliative Care Planning Coordinator (PCPC) is trained and then supported to train other nursing and personal care staff at each intervention residential aged care facility (RACF). PCPCs will be the team leader in each RACF responsible for implementing the case conferencing (CC) model as per the protocol and providing ongoing education and mentoring to other RACF staff. PCPCs from all 10 intervention facilities will attend an initial training programme for 1 week. They will learn to identify ‘triggers’ that warrant initiation of a Facilitated Case Conferencing (FCC). Where a trigger for FCC has been identified, the point of disease progression will be mapped onto relevant domains to indicate whether survival time will likely be measured in months, weeks or days. The “map” for each resident will highlight issues for discussion at CC, including pre-emptive planning for predicted deterioration. Training in facilitating general practitioner involvement will also be given to PCPCs. Ongoing support in the Intervention arm will be provided following initial training and for the rest of the study period. The team will liaise monthly with each PCPC to discuss progress and difficulties and plan support of staff training and CCs where monitoring data indicate this is required. Finally, training will assist RACF staff to provide a “palliative” space (an area which provides the resident and family a quiet, homelike private environment 24 hours per day.

PCC training will make use of experiential and adult learning approaches, guidance on how family members can be involved as much as possible in decision-making about care planning, implementation and monitoring, and support reconceptualisation from a “service focus” to person-centred focus.
Intervention code [1] 285519 0
Other interventions
Comparator / control treatment
This is a cluster randomised trial with whole RACFs randomised to either Intervention or Control. There will be no additional education, training or support provided to Control RACFs but there will also be no restriction on service-provider education and training where this is current practice. The level, duration and type of such initiatives will be documented.
Control group
Active

Outcomes
Primary outcome [1] 287783 0
Family-rated end of life (EOL) outcomes will be measured using the End of Life in Dementia (EOLD) Scales.

The EOLD Scales will be used to measure symptom-related comfort during the last seven days of life (CAD-EOLD), symptom management in the last 90 days of life (SM-EOLD) and family satisfaction with care during the last 90 days of life (SWC-EOLD).
Timepoint [1] 287783 0
The primary outcome will be measured 4 weeks following resident deaths.
Secondary outcome [1] 298825 0
Nurse-rated symptom-related comfort and symptom management will be measured using the CAD-EOLD and SM-EOLD Scales.
Timepoint [1] 298825 0
4 weeks following resident death.
Secondary outcome [2] 298826 0
Nurse-rated resident quality of life (QOL) measured using the Quality of Life in Late-stage Dementia (QUALID) Scale and EQ-5D-5L for economic evaluation purposes
Timepoint [2] 298826 0
Baseline and 6 weekly
Secondary outcome [3] 298827 0
RACF person-centred approach to care will be measured by the Care & Activities, & Interpersonal Relationships & Interactions domain of the Person-Centred Environment & Care Assessment Tool (PCECAT).
Timepoint [3] 298827 0
Baseline, 6 and 18 monthly
Secondary outcome [4] 298828 0
RAC staff attitudes to, knowledge of & confidence in providing palliative/EOL care to residents with advanced dementia will be evaluated using the Palliative Care for Advanced Dementia Questionnaire (PCADQ), a 42-item tool developed by the current team. Attitudes to dementia care more generally will be evaluated using the Dementia Attitudes Scale (DAS).
Timepoint [4] 298828 0
Before and after staff training
Secondary outcome [5] 298829 0
Quality of end of life care will be measured by rates of (inappropriate) acute care episodes and aggressive medical interventions (e.g. ventilation).
Timepoint [5] 298829 0
Baseline and 3 monthly

Eligibility
Key inclusion criteria
Eligibility criteria for clusters/RACF:
- >100 high care beds
- >50% residents with dementia.

Eligibility criteria for residents:
- a diagnosis of dementia & advanced disease as determined by Functional Assessment Staging Tool (FAST) in dementia greater than or equal to 6a,
- stable for 1 month according to RACF staff;
- Australia–modified Karnofsky Performance Status (AKPS) of less than or equal to 50;
- availability of a person legally responsible to give informed consent on their behalf;
- informed consent from a family member or other who knows the resident well.

Eligibility for family/friend “informant” (ideally the person legally responsible):
- visits the resident at least once a fortnight;
- knew the resident prior to their dementia diagnosis;
- is willing to be involved in decisions about the resident’s care;
- English proficiency sufficient to complete outcome measures

RAC staff:
all permanent nursing/personal care staff at participating RACFs.

Other health professionals (e.g. GPs):
all health professionals involved in case conferencing for participating residents will also be eligible to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Aged care facilities will be selected for approach from comprehensive lists of all facilities in each geographical area by means of a randomisation schedule intended to minimize selection bias. Facility managers will be approached via letter and telephone by the research team to canvass their initial interest. Managers expressing initial interest will be sent an information and consent form, followed by a follow-up phone call.
Facility managers and staff will be asked to identify residents who: 1) have dementia, probably in the advanced stages (with or without a confirmed diagnosis); 2) have a family member or friend who visits on a regular basis; and 3) have a person responsible to give consent to participate on their behalf.
Facility staff with care responsibilities (i.e. nurses and assistants in nursing) will also be eligible to participate. Staff will be told about the study verbally at staff meetings, provided with information and consent forms.
Finally, other health professionals who take part in case conferences for participating residents will be approached to take part.
Allocation will occur only after RACFs, staff, residents and family members have enrolled and baseline measures have been taken. Recruitment and outcome measurement will be by research assistants blinded to the purpose of the study, and each will visit only RACFs in either the Intervention or Control arm. The statistician analysing data will be blind to the identity of the RACFs. The project manager, who will need to remain unblinded to liaise with RACFs, will play no role in measuring outcomes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation will be 1:1 and occur using two stratification factors (dementia specific unit or not; part of organisation or stand alone facility) using a computer generated random allocation sequence. This method will facilitate balance in the allocation of RACFs to the FCC and UC groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/10/2012
Actual
19/02/2013
Date of last participant enrolment
Anticipated
Actual
10/06/2014
Date of last data collection
Anticipated
Actual
31/12/2014
Sample size
Target
240
Accrual to date
Final
286
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 285846 0
Government body
Name [1] 285846 0
Australian Department of Health and Ageing
Country [1] 285846 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
HammondCare
Address
Level 2, 447 Kent St
Sydney, NSW, 2000
Country
Australia
Secondary sponsor category [1] 284672 0
None
Name [1] 284672 0
Address [1] 284672 0
Country [1] 284672 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287869 0
University of New South Wales (UNSW)
Ethics committee address [1] 287869 0
Ethics committee country [1] 287869 0
Australia
Date submitted for ethics approval [1] 287869 0
Approval date [1] 287869 0
04/09/2012
Ethics approval number [1] 287869 0
HC12455
Ethics committee name [2] 288264 0
University of Technology Sydney
Ethics committee address [2] 288264 0
Ethics committee country [2] 288264 0
Australia
Date submitted for ethics approval [2] 288264 0
Approval date [2] 288264 0
03/10/2012
Ethics approval number [2] 288264 0
2012-367R
Ethics committee name [3] 288265 0
Queensland University of Technology
Ethics committee address [3] 288265 0
Ethics committee country [3] 288265 0
Australia
Date submitted for ethics approval [3] 288265 0
01/12/2510
Approval date [3] 288265 0
Ethics approval number [3] 288265 0

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

Contacts
Principal investigator
Name 34590 0
Prof Meera Agar
Address 34590 0
Faculty of Health, University of Technology Sydney, Building 10, Jones St, Ultimo, NSW 2007
Country 34590 0
Australia
Phone 34590 0
+61 2 9514 4243
Fax 34590 0
Email 34590 0
[email protected]
Contact person for public queries
Name 17837 0
Tim Luckett
Address 17837 0
University of Technology Sydney (UTS), Faculty of Health, Building 10, Level 7, 235-253 Jones St, Ultimo, NSW 2007
Country 17837 0
Australia
Phone 17837 0
+61 2 9514 4861
Fax 17837 0
+61 2 9514 4474
Email 17837 0
[email protected]
Contact person for scientific queries
Name 8765 0
Tim Luckett
Address 8765 0
University of Technology Sydney (UTS), Faculty of Health, Building 10, Level 7, 235-253 Jones St, Ultimo, NSW 2007
Country 8765 0
Australia
Phone 8765 0
+61 2 9514 4861
Fax 8765 0
+61 2 9514 4474
Email 8765 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbasePragmatic cluster randomised controlled trial of facilitated family case conferencing compared with usual care for improving end of life care and outcomes in nursing home residents with advanced dementia and their families: The IDEAL study protocol Palliative care in other conditions.2015https://dx.doi.org/10.1186/s12904-015-0061-8
EmbaseEffects of facilitated family case conferencing for advanced dementia: A cluster randomised clinical trial.2017https://dx.doi.org/10.1371/journal.pone.0181020
EmbaseFacilitated case conferences on end-of-life care for persons with advanced dementia - A qualitative study of interactions between long-term care clinicians and family members.2022https://dx.doi.org/10.1093/ageing/afab270
N.B. These documents automatically identified may not have been verified by the study sponsor.