Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000760774
Ethics application status
Approved
Date submitted
7/04/2022
Date registered
27/05/2022
Date last updated
27/10/2024
Date data sharing statement initially provided
27/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of using telehealth to train residential aged care facility staff in delivery of palliative care to residents on the rate of unplanned hospitalisation admissions and quality of end-of-life care
Scientific title
The effect of using telehealth to train residential aged care facility staff in delivery of palliative care to residents on the rate of unplanned hospitalisation admissions and quality of end-of-life care
Secondary ID [1] 306664 0
None
Universal Trial Number (UTN)
Trial acronym
IMPART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Palliative care 325599 0
End of life care 326052 0
Condition category
Condition code
Public Health 322961 322961 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The IMPART intervention is actively implemented over a 6-month period. There are 10 residential aged care facilities (RACFs) completing the stepped-wedge trial. At the start of the trial all facilities will be randomised to receive the intervention at one of 5 steps with two RACFs actively implementing the intervention during each step. Therefore the trial will occur over 2.5 years (5 X 6-month steps). The 6-month intervention involves five components described in a manual to support facility staff to implement the intervention. If the intervention is successful, the manual will be made publicly available on the NARI website so that other facilities can implement the intervention and access the templates required. After each RACF completes their active 6-month part of the intervention, the RACF will be able to use the knowledge, strategies and specialist connections and apply them for the subsequent 6-month steps of the trial and into the future. For each active 6 -month intervention period, the specialist in-reach support will be funded 0.1 EFT to support engagement with the facility. We will aim to hold meetings and workshops in person at the facility, however, we also aim to enable video-conferencing to facilitate external staff involvement.
COMPONENT 1: ESTABLISH PLANNING AHEAD TEAMS (Month 1)
The research team will work collaboratively with the RACF to establish the facility ‘Planning Ahead Team’. The RACF will identify staff to be involved, which could include nurses with a portfolio of palliative care, clinical care coordinators, or staff who have an interest in end-of-life care. We will engage senior nurses as care champions who will be able to support other staff in palliative care discussions and processes. The lead of the Planning Ahead Team will support RACF staff and work with GPs to promote end-of-life discussions with residents and families, and document decision-making. We aim to involve at least two RACF staff to maintain continuity. We will engage a GP who has an existing visiting role at the RACF. All Planning Ahead Team members will be invited to a 1-hour workshop (registered with Continuing Professional Development points) covering goals of care facilitated by a palliative care consultant.
COMPONENT 2: END-OF-LIFE CARE NEEDS ANALYSIS (Month 1)
The Planning Ahead Team will undertake a needs analysis to identify areas for improvement in end-of-life care discussions, documentation and care provision. They will review current documentation in resident files using templates designed specifically for this study. Template 1 recommends reviewing 5-10 resident files to evaluate the quality of end-of-life care planning documentation (what is documented, whether resident wishes are incorporated and whether it has been recently reviewed). A second template prompts evaluating documentation from 5-10 residents who have died in the last 6 months. Questions include place of death, services involved, recognition of dying, whether end-of-life care was consistent with residents’ wishes and end-of-life planning documentation.
These templates will help inform completion of the Needs Analysis Checklist that assess the extent to which each facility’s existing processes, policies and procedures enable shared-decision making, person-centred care and are responsive to cultural, language and spiritual requirements and values. This Checklist, designed specifically for this study, summarises overall RACF processes, policies and procedures. The Needs Analysis Checklist will be completed jointly by the Planning Ahead Team with support from the research team and input from the external palliative care and aged care specialists.
The research team will invite the Planning Ahead Team to complete a survey assessing confidence in providing, discussing and planning for end-of-life care. This survey is based on existing end-of-life confidence measures (Dowling M, et al, …Journal of Palliative Medicine, 2020. 23[2]: 179-183 and Phillips J, et al. … Int J Nurs Stud, 2011. 48[9]: 1096-100). The research team will assess the availability and confidence of RACF staff in using end-of-life related equipment such as syringe drivers, lifting machines, pressure relieving devices or catheter equipment and the availability of medication related to end of life including Imprest stock. Planning Ahead Teams will explore opportunities for obtaining resident and family input on end-of-life care planning undertaken in the facility. They will also review documented complaints and complements to the facility and see whether any relate to end-of-life care.
COMPONENT 3: WORKSHOP WITH PLANNING AHEAD TEAMS (Month 2) AND ACTION PLANNING (Months 2-6)
The research team will facilitate an initial workshop with the Planning Ahead Team. During this 1-2-hour workshop, the research team will present findings from the needs analysis, highlighting strengths and challenges in current end-of-life care practices. For instance, the research teams will synthesise data from the Needs Analysis Checklist and the staff survey to reflect on practice. This will provide a comprehensive understanding of the end-of-life care needs in the facility, incorporating views of RACF staff, external palliative care specialists and GPs. We will discuss avenues for addressing needs and develop an action plan using the Action Plan Template developed for this study. This approach aims to engage facility staff with areas of practice change that they have identified and consider relevant to their practice.
During the workshop, future meetings and steps for the Planning Ahead Team will be planned to monitor the action plan and outcomes. Over the remaining 4 months of the intervention, the Planning Ahead Team will meet approximately once a month for 1-hour to implement and review progress of the action plan. The external geriatric or palliative care specialist will contact the RACF Planning Ahead Team through a 30 minute monthly telephone/video call to discuss progress, challenges and offer information and training as needed. While developing the action plan, we will identify ways of involving residents and families in implementing the action plan, e.g. by including them in future discussions about end-of-life care processes. At the end of the 6 month intervention and to evaluate the impact of the action plan on practice, we will repeat some data collection. For example, repeating the review of resident files to see whether documentation has improved, repeat the staff end-of-life care survey or review policies, complaints and complements.
COMPONENT 4: IMPETUS-D PLUS ONLINE TRAINING (Months 2-6)
RACF staff will receive access to the existing ‘Improving Palliative care Education and Training Using Simulation in Dementia (IMPETUS-D) validated online training package (Tropea J, et al. ...BMC Pall Care, 2019. 18(1): 86). During the workshop described in Component 3, the Planning Ahead Team will review the modules available in the IMPETUS-D training set to identify which modules may be useful for staff in their facility. Depending on the goals identified in the action plan, they may choose training for all RACF staff or target training to specific staff, such as those in the Planning Ahead Team. It may be useful to use a section of a module or run a workshop/meeting to discuss a module and the implications for practice at that RACF. The research team will send reminders to the Planning Ahead Team to complete training as planned in the action plan. There are 11 modules that can be completed online using a computer/laptop, tablet or smartphone. Each module takes 15-30mins and contains video simulation. Topics: recognising end of life; Goals of Care planning and discussions; distinguishing dementia from delirium, managing symptoms including pain, breathlessness, not eating/drinking, and terminal restlessness; communicating with residents and families, and supporting staff when a resident dies. The training was developed for end-of-life care for people with dementia but encompasses skills required for end-of-life care for all residents. The research team will highlight other resources that may address information needs.
COMPONENT 5: SPECIALIST TELEHEALTH IN-REACH END-OF-LIFE SUPPORT (Months 2-6)
Local palliative care and aged care specialists will be engaged from the start of the IMPART program through their involvement in the Planning Ahead Teams in Components 1 and 3. The workshops with the Planning Ahead Teams will help RACF staff get to know the specialist team, establish communication channels and plan for specialists to provide training or shadowing/observations using online technology. An approach could involve the Planning Ahead Team and the GP completing IMPETUS-D modules and discussing this with the specialist team. This could be followed by a collaborative end-of life discussion between the resident and/or family member(s) with RACF staff, the GP and the specialist clinician using telehealth. This will involve immediate feedback after the case conference from the specialist clinician. While the IMPETUS-D training provides videos of professionals having these conversations, there may be additional benefits of getting direct feedback from an expert. We will use video-conferencing to foster rapid communication between RACFs and specialists.
FIDELITY TESTING
Access to and completion of IMPETUS-D modules is digitally recorded and matched to individual RACFs. A member of each Planning Ahead Team and their connected specialist service will maintain an activity log documenting time spent (to the nearest 15min) on different components of the intervention. The research team will make monthly calls to the RACF Planning Ahead Team and their specialist service to monitor progress with the intervention. We will collect completed Action Plans to monitor extent to which plans were developed and implemented and also monitor this via telephone calls with the Planning Ahead Team.
Intervention code [1] 323104 0
Treatment: Other
Comparator / control treatment
The intervention will be compared with usual care (control/waiting), this would include routine practice provided in residential aged care which could include advance care planning, goals of care and specialist residential care in-reach.
Control group
Active

Outcomes
Primary outcome [1] 330768 0
Rate of unplanned hospitalisations per 1000 bed days of aged care residents extracted from the Victorian Admitted Episodes Dataset
Timepoint [1] 330768 0
6 months prior to the active intervention (pre-trial), and every 6 months until 6 months after the final cluster has been randomised
Secondary outcome [1] 407488 0
Rate of emergency department presentations per 1000 bed days of aged care residents extracted from the Victorian Emergency Minimum Dataset
Timepoint [1] 407488 0
6 months prior to the active intervention (pre-trial), and every 6 months until 6 months after the final cluster has been randomised
Secondary outcome [2] 407489 0
Length of stay in days of unplanned hospital admissions per 1000 bed days of aged care residents extracted from Victorian Admitted Episodes Dataset
Timepoint [2] 407489 0
6 months prior to the active intervention (pre-trial), and every 6 months until 6 months after the final cluster has been randomised
Secondary outcome [3] 407490 0
Quality of life – Aged Care Consumer (QOL-ACC).
Timepoint [3] 407490 0
At baseline (pre-trial), and every 6 months until 6 months after the final cluster has been randomised
Secondary outcome [4] 407491 0
Cost-effectiveness (Costs of implementing trial - staffing, resources etc recorded through activity logs; Medicare and Pharmaceutical Benefits Scheme data for health care costs; hospitalisation and emergency presentation costs
Timepoint [4] 407491 0
Every 6 months until 6 months after the final cluster has been randomised
Secondary outcome [5] 408479 0
Satisfaction with Care at End of Life survey with family members of residents who die during the trial period (both in the intervention and the control/waiting arm)
Timepoint [5] 408479 0
2-4 months after the resident's death
Secondary outcome [6] 408480 0
Comfort Assessment in Dying (CAD) survey with family members of residents who die during the trial period (both in the intervention and the control/waiting arm)
Timepoint [6] 408480 0
2-4 months after the resident's death
Secondary outcome [7] 408481 0
ICECAP- Close Person Measure with family members of residents who die during the trial period (both in the intervention and the control/waiting arm)
Timepoint [7] 408481 0
2-4 months after the resident's death

Eligibility
Key inclusion criteria
Residents: All residents living permanently in the participating RACFs will be eligible to take part in this research.
Family members or friends of eligible residents, including families of residents who die during the study and wish to take part in the post-death survey.
GPs, RACF senior nurses and clinical care coordinators liaising with or working within the participating RACFs will 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
Nil

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation of residential aged care facilities by facility size. Once the 10 RACFs are determined, we will randomly select RACFs for allocation to each sequence. Considering potential variation in the size of RACFs, this process will be stratified to ensure that the largest sites are not all randomly assigned to the last roll-out block. To prevent the two largest (or vice versa, two smallest) RACFs being randomly assigned to the first or last sequence, the randomisation will be conducted in two parts. After sorting the 10 RACFs from smallest to largest in size based on number of residents, one from each of the 5 pairs (i.e. 1st-2nd smallest considered as pair 1, 3rd-4th smallest as pair 2,… etc.) will be randomly assigned to either Group A or Group B, resulting in 5 RACFs included in each group. The 2nd step will be to randomly order the 5 RACFs in Group A and assign them to stepped wedge sequences 1 to 3. The 5 RACFs in Group B will then be randomly ordered with the first RACF in Group B assigned to the remaining spot in sequence 3, and the remaining 4 RACFs assigned based on the random ordering to sequences 4 and 5. This may, by chance, result in the two largest (or smallest) being assigned to sequence 3, but it will ensure that the two largest (or two smallest) are not both assigned to sequences 1 or 5. If the size of the RACFs does not vary considerably, then the stratified randomisation approach will be abandoned, and simple random ordering of the 10 RACFs into the 5 clusters will be conducted. Randomisation will be completed by the project statistician, external to the research team and using Stata version 15.1 and Ralloc software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Step-wedged cluster controlled trial
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical methods depend on the type and distribution of the outcome measures and will include, for example, descriptive analysis, mixed-effects Poisson regression models, sensitivity tests, and correlations. Statistical analyses will be conducted using Stata version 15.1. Randomisation will be conducted using Stata version 15.1 and Ralloc software.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2022
Actual
24/05/2023
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
2250
Accrual to date
948
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310993 0
Government body
Name [1] 310993 0
National Health and Medical Research Council
Country [1] 310993 0
Australia
Primary sponsor type
Other Collaborative groups
Name
National Ageing Research Institute
Address
34-54 Poplar Road, Gate 4, Building 8 (PO Box 2127) Royal Melbourne Hospital Parkville Victoria 3050
Country
Australia
Secondary sponsor category [1] 312303 0
None
Name [1] 312303 0
Address [1] 312303 0
Country [1] 312303 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310546 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 310546 0
Ethics committee country [1] 310546 0
Australia
Date submitted for ethics approval [1] 310546 0
29/03/2022
Approval date [1] 310546 0
19/05/2022
Ethics approval number [1] 310546 0

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

Contacts
Principal investigator
Name 118034 0
Prof Kwang Lim
Address 118034 0
The Royal Melbourne Hospital City Campus, Level 6 North 300 Grattan Street, Parkville Victoria 3050
Country 118034 0
Australia
Phone 118034 0
+61 3 9342 4186
Fax 118034 0
Email 118034 0
[email protected]
Contact person for public queries
Name 118035 0
Anita Goh
Address 118035 0
The National Ageing Research Institute 34-54 Poplar Road, Gate 4, Building 8, Royal Melbourne Hospital Parkville Victoria 3050
Country 118035 0
Australia
Phone 118035 0
+61 3 8387 2377
Fax 118035 0
Email 118035 0
[email protected]
Contact person for scientific queries
Name 118036 0
Anita Goh
Address 118036 0
The National Ageing Research Institute 34-54 Poplar Road, Gate 4, Building 8, Royal Melbourne Hospital Parkville Victoria 3050
Country 118036 0
Australia
Phone 118036 0
+61 3 8387 2377
Fax 118036 0
Email 118036 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




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.