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Trial registered on ANZCTR


Registration number
ACTRN12618002012257
Ethics application status
Approved
Date submitted
11/12/2017
Date registered
14/12/2018
Date last updated
14/12/2018
Date data sharing statement initially provided
14/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving Palliative Care Education and Training Using Simulation in Dementia (IMPETUS-D)
Scientific title
A simulation training program to improve end stage dementia care in residential aged care facilities and reduce hospital transfers: the IMPETUS-D cluster randomised trial
Secondary ID [1] 293576 0
None
Universal Trial Number (UTN)
U1111-1206-4537
Trial acronym
IMPETUS-D
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 305814 0
Palliative care 305815 0
Condition category
Condition code
Neurological 305033 305033 0 0
Dementias
Public Health 305147 305147 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Those in the intervention group will participate in IMPETUS-D a screen-based simulation training program. The training program consists of 11 modules that can be accessed on PC, laptop, tablet or smartphone. covering key aspects of high quality palliative care for people with dementia towards the end of life. These aspects were judged to be the most relevant for nursing and care home staff, informed by multiple sources including, staff working in residential care, published literature, and the advice of the IMPETUS-D Project Working and Advisory Group which included palliative care, dementia and aged care experts.

The following is an outline of the overview of the content for each module:
Module 1: This module describes the natural progression of advanced dementia and how to recognise when deterioration is due to dementia versus delirium. The module introduces Nancy Thompson a resident with dementia, and in two video-based scenarios Nancy declines (i) due to the progression of dementia and (ii) due to an acute delirium.
Module 2: This module focuses on caring for a person with advanced dementia when they are dying. It includes regular discussions with the family so everyone is on the same page, and focusing care on maximising wellbeing, comfort and dignity, and minimising distress. The module includes audio recordings of personal care attendants (PCAs) and family members talking about 3 residents who received suboptimal care, and asks learners to write down their thoughts on what could have been done differently.
Module 3: This module discusses the reasons why people with advanced dementia are typically best cared for in the care home, and describes the challenges people with advanced dementia face in the busy hospital environment. The module introduces Antonio Conti a resident with dementia and his wife Bianca. It includes a video-based scenario where Bianca confronts a PCA as she is very worried that Antonio may need to go into hospital, as last time he went to hospital, things did not go well.
Module 4: This module gives an introduction to Goals of Care (GOC) plans, and highlights that finding out what’s important to the person is vital to providing best care. It follows the development of a GOC plan including a GOC discussion between Antonio, his family, the care manager and general practitioner.
This module includes audio-recordings of a good GOC discussion with Antonio’s GP and family; and audio-recordings from care home staff giving their perspective on GOC discussions.
Module 5: This module describes what is needed to be a high quality and best practice Goals of care (GOC) plan. It provides examples of how to best use GOC plans for residents with dementia, and describes situations when a person with advanced dementia needs to go to hospital. In this module a video-based scenario involving Antonio Conti demonstrates there are exceptions that require transfer to hospital.
Module 6: This module discusses pain and the challenges in managing pain in people with advanced dementia. It highlights the importance of how to recognise it, document it, and act on it including speaking up for people with dementia who are in pain. In addition, it describes some of the myths and truths about opioid use. . This module introduces Mrs Keya Basu a resident with advanced dementia. It includes a video-based scenario where Mrs Basu’s daughter Priya can hear her mother crying out in pain while a wound dressing is being changed.
Module 7: This module focuses on recognising the dying phase, including reduced eating and drinking, and helping families understand that reduced eating and drinking at the end of life is normal. This module includes a video-based scenario where Mrs Basu’s daughter Priya tells a PCA she is concerned her mother is not eating or drinking, and questions the need for a drip or feeding tube.
Module 8: This module has 2 parts. The first discusses focussing on what is most important to the person when they are dying and ways to keep a person as comfortable as possible. The second part describes terminal restlessness a common end of life symptom, and how care staff can recognise and manage it. This module includes a scenario where Mrs Basu’s daughter Priya is talking to a PCA about her mother being restless.
Module 9: This module focuses on changes in breathing at end of life, what to expect as death approaches and ways to support the family. It also discusses the concerns care staff may have as a resident approaches death and includes reflection of learners’ real experiences. This module includes a scenario with a PCA expressing concerns about “what if Mrs Basu dies on my shift?”
Module 10: This module raises the importance of communicating openly, honestly and continuously with residents and their family members. Strategies for this communication are offered for difficult conversations. Three video-based scenarios of challenging situations involving Antonio Conti’s family are presented.
Module 11: This module shifts the focus of caring from residents to care providers. It encourages carers to consider their own feelings about death and dying and how they manage these feelings when a resident is at the end of their life and then dies. It offers strategies to manage emotional wellbeing and ways to contribute a compassionate culture in their workplace. The module includes audio recordings of PCAs talking about some real experiences, and encourages learners to role play a conversation that acknowledges feelings.

Each module has been designed to take approximately 15 minutes, and participants can access the modules at their discretion.

Modules 1-3, 6-9 and 11 have been designed for Personal carers as the targeted learners; and Modules 4 and 5 have been designed for nurses as the targeted learners. Module 10 has been designed for all care home staff. All modules will be available to all staff to participate in throughout the study timeframe.

Personal carers (or PCAs) will be expected to complete at least 5 of the modules – modules 1-3 and 10, and one symptom management module (Modules 6-9). The remaining modules on goals of care discussions, goals of care plans, and staff well-being will be recommended for them to complete.

Nurses will be expected to complete the two goals of care modules and the communication module. All other modules will be recommended for nurses to complete.

We are aiming for 80% of staff to complete the 'expected to complete' modules.

There will be a 2-month training period during which time staff in the intervention group will be encouraged by the project team to participate in the training program. During the 2-month training period project consultants will send email or text reminders on a weekly basis, as well as attend staff meetings in person where participation rates are low. Outcome data will not be collected until after the 2-month training period. Participants will continue to be able to access the training program as many times as they want and need throughout the study time-frame. The amount of usage (hits and time spent) and module completion data will be collected via the learning management system (LMS).
Intervention code [1] 299829 0
Other interventions
Comparator / control treatment
Those in the control group will have access to usual or standard training opportunities which includes training that may be provided by the facility or health care professionals visiting the facility or may be involve no training during the trial time-frame.
Control group
Active

Outcomes
Primary outcome [1] 304198 0
Composite primary outcome: Proportion of hospital transfers or deaths in hospital over 6 months in intervention group (IMPETUS-D) compared to the control group.
Hospital transfer and deaths in hospital data will be extracted from the facilities records (residents' progress notes and from online system as a "resident leave event").
Timepoint [1] 304198 0
6 months after the 2 month training period
Secondary outcome [1] 341211 0
Proportion of hospital transfers or deaths in hospital at 12 months follow up..
Hospital transfer and deaths in hospital data will be collected from the facilities records (progress notes and online as a "resident leave event").
Timepoint [1] 341211 0
12 months after the 2 month training period
Secondary outcome [2] 341212 0
Proportion of hospital transfers at 6 months.
Hospital transfer data will be collected from the facilities records (progress notes and online system as a "resident leave event").
Timepoint [2] 341212 0
6 months after the 2 month training period
Secondary outcome [3] 341213 0
Proportion of hospital transfers at 12 months.
Hospital transfer data will be collected from the facilities records (progress notes and online system as a "resident leave event").
Timepoint [3] 341213 0
12 months after the 2 month training period
Secondary outcome [4] 341214 0
Proportion of deaths in residential aged care facilities (RACF) at 6 months
Death data will be collected from the facilities records (progress notes and online system as a "resident leave event").
Timepoint [4] 341214 0
6 months after the 2 month training period
Secondary outcome [5] 341215 0
Proportion of deaths in RACF at 12 months.
Death data will be collected from the facilities records (progress notes and online system as a "resident leave event").
Timepoint [5] 341215 0
12 months after the 2 month training period
Secondary outcome [6] 341216 0
Uptake of Goals of Care (GOC) plans at 6 months.
This data will be collected from the residents' records/files.
Timepoint [6] 341216 0
6 months after the 2 month training period
Secondary outcome [7] 341217 0
Uptake of Goals of Care (GOC) plans at 12 months.
This data will be collected from the residents' records/files.
Timepoint [7] 341217 0
12 months after the 2 month training period
Secondary outcome [8] 342630 0
Change in staff knowledge and attitudes about palliative and end of life dementia care. This will be measured using the Questionnaire on Palliative Care in Advanced Dementia (qPAD). The qPAD is a validated 2-part instrument consisting of 23-item knowledge test and 12-item attitude scale. qPAD total scores will be used for the analysis.
Timepoint [8] 342630 0
after the 2-month training period and repeated at 6 months follow-up
Secondary outcome [9] 342631 0
Change in bereaved carer/family perception of care, using a bereaved carer/family survey developed by L Reymond et al AHR 2011; 35, 350-356. The survey has not been validated.
Timepoint [9] 342631 0
6 and 12 months after initial 2 month training period

Eligibility
Key inclusion criteria
Inclusion criteria: Allity Residential Aged Care Facilities (RACF) in Melbourne, Adelaide and Sydney with 20 or more residents with a diagnosis of dementia will be included in the study.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Care homes with low numbers of residents living with dementia (<20 residents)

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)
Individual RACFs (clusters) in the trial will be randomised, with staff at the RACF receiving either the intervention training or the control group. The allocation sequence will be generated by an independent statistician using a computer-generated allocation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation will use blocks of 4 stratified by city location (Sydney, Melbourne or Adelaide) and facility size (small or large) based on the total number of residents. Small RACFs are defined as having 70 or less residents and large RACFs defined as having greater than 70 residents living in the care home. The randomisation list will be stored and maintained in a secure location by a statistician who is independent from trial recruitment or training so as to preserve blinding.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Cluster
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
POWER ANALYSIS:
In this study 24 facilities (12 intervention sites and 12 control sites) will be recruited. The power analyses were based on the following assumptions: proportion of composite events of 0.65 and 0.85 over 12 months of follow-up in the intervention and control groups respectively, two-sided significance level of 0.05 (alpha), 12 clusters (facilities) in each study arm, 20 – 25 residents with dementia in each cluster, an Intra-Cluster Correlation (ICC) of 0.05. With these assumptions, the minimum power to observe a difference of proportion by 0.20 between the intervention and control group is 94%. If the number of residents with dementia per cluster reduces to 15 only, the power to observe this difference reduces to 0.93%. If the cluster size in each group is reduced to 10 and the number of residents in each cluster is only 15, then the study would have a power of 88% to observe a difference in proportion by 0.20.

The assumptions on the composite of events for this study were based on the limited information reported in the study by Dr Ruth Martin et al. The power analysis was performed using PASS 15.

STATISTICAL METHODS
All analyses will be conducted on an intention-to-treat basis. The basic statistics will be presented by number (%), mean (SD), median (Q1, Q3), mean (95% CI) or median (95% CI of median), as appropriate. For analyses of primary and secondary outcomes, the fundamental principle of analysing data from cluster randomised trials will be followed, where appropriate adjustments for cluster level variations will be accounted for to ensure robust inferences.

To compare the proportion of composite events for the primary outcome and the proportions for individual components of the primary outcome (secondary outcomes), logistic regression models will be used with standard errors weighted by the cluster effects. The uptake of GOC is a binary measure at the individual resident level, and will be analysed using logistic regression. The estimated proportions and 95% confidence intervals will be presented, along with the p value for comparison between intervention and control groups. All statistical tests will be two-sided with a significance level of 0.05.

Additional exploratory analyses will be conducted to evaluate the primary and secondary outcomes of the study, adjusting for potential confounders such as age, sex and comorbidities.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC

Funding & Sponsors
Funding source category [1] 298191 0
Government body
Name [1] 298191 0
Australian Government Department of Health
Address [1] 298191 0
Health Grants and Network - Tasmania
Australian Government Department of Health
Location: Level 1, 100 Melville Street, Hobart TAS 7000
Country [1] 298191 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
Royal Melbourne Hospital
300 Grattan Street Parkville 3050
Country
Australia
Secondary sponsor category [1] 297292 0
None
Name [1] 297292 0
Address [1] 297292 0
Country [1] 297292 0
Other collaborator category [1] 279849 0
Commercial sector/Industry
Name [1] 279849 0
Allity Pty Ltd
Address [1] 279849 0
Level 1, 39 Albany Street Crows Nest, NSW 2065
Country [1] 279849 0
Australia
Other collaborator category [2] 279850 0
University
Name [2] 279850 0
University of Melbourne
Address [2] 279850 0
University of Melbourne Parkville VIC 3010
Country [2] 279850 0
Australia
Other collaborator category [3] 279851 0
University
Name [3] 279851 0
Monash University
Address [3] 279851 0
Scenic Blvd, Clayton VIC 3800
Country [3] 279851 0
Australia
Other collaborator category [4] 279852 0
University
Name [4] 279852 0
Deakin University
Address [4] 279852 0
221 Burwood Hwy, Burwood VIC 3125
Country [4] 279852 0
Australia
Other collaborator category [5] 279853 0
Hospital
Name [5] 279853 0
Monash Health
Address [5] 279853 0
246 Clayton Road, Clayton, Victoria 3168
Country [5] 279853 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299203 0
Melbourne Health HREC
Ethics committee address [1] 299203 0
Royal Melbourne Hospital
Level 2 South West
300 Grattan Street
Parkville Victoria 3050
Ethics committee country [1] 299203 0
Australia
Date submitted for ethics approval [1] 299203 0
27/09/2017
Approval date [1] 299203 0
30/11/2017
Ethics approval number [1] 299203 0
HREC/17/MH/336

Summary
Brief summary
This study will evaluate the effectiveness of IMPETUS-D an online simulation training program for staff working in residential aged care facilities (RACF). As the residential aged care workforce is diverse, fragmented and involves shift work, training programs must be engaging and easily accessible. IMPETUS-D aims to reduce transfers to acute hospitals by improving staff knowledge and confidence to deliver end of life or palliative care within the facility, and to enhance consumer satisfaction with palliative care .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79638 0
Prof Kwang Lim
Address 79638 0
Level 6 North, Main block
Royal Melbourne Hospital
300 Grattan Street
Parkville VIC 3050
Country 79638 0
Australia
Phone 79638 0
+61 0416126047
Fax 79638 0
Email 79638 0
Kwang.Lim@mh.org.au
Contact person for public queries
Name 79639 0
Ms Joanne Tropea
Address 79639 0
Melbourne EpiCentre - Level 7 East Main Block
Royal Melbourne Hospital
300 Grattan Street
Parkville VIC 3050
Country 79639 0
Australia
Phone 79639 0
+610401338230
Fax 79639 0
Email 79639 0
Joanne.Tropea@mh.org.au
Contact person for scientific queries
Name 79640 0
Prof Kwang Lim
Address 79640 0
Level 6 North, Main block
Royal Melbourne Hospital
300 Grattan Street
Parkville VIC 3050
Country 79640 0
Australia
Phone 79640 0
+61 0416126047
Fax 79640 0
Email 79640 0
Kwang.Lim@mh.org.au

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 participant data underlying published results only - unidentifiable data on the primary and secondary outcomes
When will data be available (start and end dates)?
Data will be available after analyses is finalised and report / publication has been submitted and approved. No end date.
Available to whom?
Collaborators, funding body, case by case basis at the discretion of the primary sponsor
Available for what types of analyses?
For IPD meta-analysis
How or where can data be obtained?
We will use a University of Melbourne and Melbourne Health approved data sharing repository platform such as Figshare. Access subject to approval by Principal Investigator.
What supporting documents are/will be available?
No other documents available
Summary results
No Results