Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001282774
Ethics application status
Approved
Date submitted
31/08/2022
Date registered
30/09/2022
Date last updated
5/05/2023
Date data sharing statement initially provided
30/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a clinical pathway on health and wellbeing outcomes for people with dementia associated behavioural changes living in residential aged care facilities.
Scientific title
Testing the efficacy of a clinical pathway for best practice in BPSD care: A randomised controlled trial
Secondary ID [1] 307800 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
For information on the development of the draft pathway please see:
Kennedy KJ, Eckert M, Forsythe D, Wagner J, Sharplin G. Development of a clinical pathway for behavioural and psychological symptoms of dementia care: A tool to improve resident outcomes. Australasian Journal on Ageing. 2022.

Health condition
Health condition(s) or problem(s) studied:
Dementia 327379 0
BPSD 327380 0
Condition category
Condition code
Neurological 324502 324502 0 0
Dementias
Public Health 324503 324503 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cluster randomised controlled trial
Intervention (Arm 1):
The trial will be conducted with three aged care providers. Two memory support units from each provider will be invited to participate in the trial.
The clinical pathway will become standard practice for management of behavioural and psychological symptoms of dementia (BPSD) at three intervention sites for 12-months. Clinical outcome data will be collected at baseline and 12-months following the intervention. A clinical pathway is a tool that provides a structured plan of care contextualised to the local setting, with the aim of standardising care for a clinical issue. They support the translation of clinical guidelines and available evidence into local protocols and clinical practice, and are used to improve quality of care, reduce variation in clinical practice, and maximize treatment or health outcomes in selected population groups. Clinical pathways allow care workers to address changing needs over time and develop targeted health interventions to support quality of life for people living with dementia.
Care staff and managers from the intervention arm of the study will work with pathway developers to contextualise the pathway to their unique clinical setting prior to the implementation period. This will involve meetings with the site manger, nurse manager and clinical care leaders to ensure the pathways evidence-based practice format is incorporated into site-specific documentation and reporting lines where appropriate, and replacing the current documentation and practices where needed (this decision will be based on whether the local documentation and processes meet the current best practice evidence and legislative requirements). Based on the feasibility trial, it is expected that this stage will require several 30 to 60-minute meetings, and is expected to take approximately 1 month to finalise across all three sites. Once the pathway has been contextualised to the local setting, the care staff will be trained in the use of the pathway by the pathway developers (this will be the researchers and clinical staff who have worked on the pathway contextualisation for that site). Training will be a half day face to face session and will be conducted in the 2 weeks prior to the pathway implementation. Multiple training sessions will be conducted to ensure all care staff have the opportunity to attend. Reminders of the training and the pathway trial will occur in shift handovers for these two weeks. Training will cover the changes to documentation and practice required at the site, and will introduce the pathway instruction guide and flow charts. Contact details for the research team and the name of the local site champion will be provided to all staff undertaking training, with instruction to contact either for any queries, and a community of practice within the local site will be encouraged.
Care staff will include registered nurses, enrolled nurses, and personal care workers.
The intervention:
A detailed instruction guide was developed to support health and social care staff in the identification, monitoring and support of people living with dementia who are experiencing BPSD. The guide comes with two colour-coded flowcharts for quick reference, to assist staff with determining the best management and care strategies for each person living with dementia. One flowchart is specific for those with a pre-existing antipsychotic prescription and one for those with no antipsychotic prescription. The instruction guide, also colour-coded based on the risk levels, contains these quick reference flowcharts and gives greater details on the processes and documentation required for each step. The pathway has an underlying focus of person-centred care and involvement and incorporates the individuals social background, hobbies, needs and wants as identified by the person, their carers, and family members. A comprehensive health and wellbeing review should be undertaken on admission to the site and incorporates three health areas, and uses the current full assessment and care planning process in place at the site to complete this review. 1. Clinical review: The clinical team undertake a holistic review, done in collaboration with the person and their primary care giver, of all aspects of care including key areas such as pain, continence, nutrition and hydration. Medical reviews: The persons GP undertakes (or is consulted on) an appropriate medical review to ensure there are no underlying medical conditions or polypharmacy interactions that may impact on the persons health and wellbeing. Wellbeing review: The Wellbeing coordinator (or equivalent person(s)) undertake a full lifestyle review and develop a person-centred care plan to support the persons wellbeing, focusing on what is important to the individual. Regular clinical, medical and wellbeing reviews based on this information, should be undertaken at signs of change in behaviour or decline in health, or at 6 monthly intervals.
A comprehensive health and wellbeing review (for a new admission to the site) can take up to 6 hours. The care plan update based on behaviour changes takes approximately 2-5 hours depending on complexity of the resident’s health or the changes in bahaviour that have been noted.
In the instruction guide ‘Risk’ is defined as the potential for harm or danger (physical or psychosocial) to the person living with dementia, or those around them. The degree of risk is assigned depending on three aspects that need to be assessed together: the severity of the behaviour; the context of the behaviour; and the resources available to manage the behaviour and the situations surrounding it. The purpose of the instruction guide is to provide an evidence-based clinical pathway with a focus on collaboration with the person, their representatives, and the broader clinical care team. Tools to achieve this are incorporated into the pathway, and follow current best practice evidence. The clinical pathway follows a stepped care model based on a colour-coded traffic light system.
• Green represents ‘prevention’; the person living with dementia does not have any BPSD and is of no or low risk to themselves or others, or has BPSD with effective non-pharmacological strategies to minimise BPSD and is of no or low risk. The focus in this stage is on monitoring health and wellbeing and maintaining preventative measures (personalised routines and activities that maintain the persons wellbeing, i.e.: gardening, folding laundry, walking or activities/sensory boxes). Prevention involves regular assessment through 6 monthly care planning process’ and early identification of changes in behaviour via daily care staff monitoring and reporting of behaviours.
• Amber represents ‘watchful waiting’; mild to moderate BPSD is present; the person living with dementia has mild or moderate risk. Ongoing medical and wellbeing reviews are required to identify triggers or unmet needs, and non-pharmacological changes (environment, social, activities etc.) are implemented. Examples of person centred care strategies are supplied (these cover environmental changes, activities and programs, alterations to nursing care, physical strategies and psychosocial programs/therapies), and records of what works for each individual are kept for future reference.
• Red represents ‘specific intervention’; severe BPSD is present, the person living with dementia is a high risk to themselves or others. The specific intervention is split into two sections; those not currently prescribed an antipsychotic (new prescription) and those who are currently prescribed an antipsychotic (existing prescription). Interventions to prevent harm can include referral to acute or specialist services, and/or the swift introduction of nonpharmacological and pharmacological approaches to risk mitigation. It is appropriate to refer the person to a specialist (either internal or external) for individual interventions or pharmacological intervention. Existing prescriptions are monitored by staff and proscribing GP/Geriatrician, and regular reviews for efficacy, with consideration of deprescribing are undertaken. New prescriptions are monitored for adverse effects including metabolic syndrome and if there is no efficacy observed within a relatively short timeframe (usually one to two weeks), treatment should be discontinued. Pharmacological options are based on the best available evidence and should be used within an overall care plan tailored to the person. All antipsychotic prescriptions need to be monitored carefully and reviewed every 4 weeks with deprescribing considered at 12 weeks.
Intervention code [1] 324262 0
Prevention
Intervention code [2] 324263 0
Treatment: Other
Comparator / control treatment
Treatment as usual. No intervention or education will be provided, Control sites will carry on with their current mode of care delivery and documentation.
If the intervention is proven successful, the three control sites will receive the intervention following the 12 month trial period.
Control group
Active

Outcomes
Primary outcome [1] 332391 0
The primary outcome measure will be change in the number of antipsychotic prescriptions specific to BPSD per trial participant. This information is routinely collected on the medication register and will be made accessible to the research team
Timepoint [1] 332391 0
At baseline (for the 12 months prior) and at 12 months after the intervention commences
Secondary outcome [1] 413311 0
change in quality of life of the participants as measured by the Australian Government National Aged Care Mandatory Quality Indicator Program.
Timepoint [1] 413311 0
At Baseline and 12 months after intervention commences
Secondary outcome [2] 413314 0
Number of BPSD-related incident reports/documentation (e.g., violence, aggression),
This routinely collected audit data will be made accessible to the research team.
Timepoint [2] 413314 0
At baseline (for the 12 months prior) and at 12 months after the intervention commences
Secondary outcome [3] 413987 0
Call outs for Dementia Support Australia/specialist referral.
This routinely collected audit data will be made accessible to the research team.
Timepoint [3] 413987 0
At baseline (for the 12 months prior) and at 12 months after the intervention commences.
Secondary outcome [4] 413988 0
Hospitalisations.
This routinely collected audit data will be made accessible to the research team.
Timepoint [4] 413988 0
At baseline (for the 12 months prior) and at 12 months after the intervention commences

Eligibility
Key inclusion criteria
Eligibility criteria for staff survey and focus group participation include a) being over 18 years of age, and b) having worked at a site for a minimum of three months during the study period.
Elibibility criteria for residents: must have been a resident in the facility for at least one month and they or their nominated decision maker must consent to joint completion of the quality of life scale .
Eligibility criteria for sites include RACFs with Memory Support Units that have more than one site available for randomisation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
For survey and focus group participation: Under 18 years, new to the site (less than 3 months), short term agency/backfill staff.

For sites: RACFs without a dedicated memory support unit or equivelent, single RACF (must have multiple locations that can be randomised to treatment or control in order to ensure local site processes do not confound pathway implementation or use).

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)
Facilities will be randomised to the control or experimental condition using randomisation software.
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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on a standard RCT with 80% power, alpha=0.05, an effect size of 0.7 (from our pilot data), two time points (baseline and 6 months), and a correlation over time of 0.5, then 27 residents per study group would be required. However, this needs to be inflated because of the clustered design. Assuming an average of 6 participants per facility and an ICC of 0.05 (Agar et al., 2015) the required sample size is 33 per group, or 6 residents per facility. The primary outcome will be analysed using mixed effects Poisson regression with clustering by individual within facility. Similarly, Quality of Life will be analysed using a linear mixed effects regression with clustering

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/10/2022
Actual
10/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
58
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 312070 0
Charities/Societies/Foundations
Name [1] 312070 0
Nurses Memorial Foundation of South Australia
Country [1] 312070 0
Australia
Funding source category [2] 312112 0
University
Name [2] 312112 0
University of South Australia
Country [2] 312112 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
UniSA City East Campus, Clinical & Health Sciences
Centenary, GPOBox 2471, SA 5001
Country
Australia
Secondary sponsor category [1] 313634 0
None
Name [1] 313634 0
Address [1] 313634 0
Country [1] 313634 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311478 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 311478 0
Ethics committee country [1] 311478 0
Australia
Date submitted for ethics approval [1] 311478 0
21/09/2022
Approval date [1] 311478 0
15/12/2022
Ethics approval number [1] 311478 0
204960

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

Contacts
Principal investigator
Name 121238 0
Prof Marion Eckert
Address 121238 0
UniSA City East Campus, Clinical & Health Sciences
Playford, GPOBox 2471 SA 5001
Country 121238 0
Australia
Phone 121238 0
+61883021455
Fax 121238 0
Email 121238 0
[email protected]
Contact person for public queries
Name 121239 0
Marion Eckert
Address 121239 0
UniSA City East Campus, Clinical & Health Sciences
Playford, GPOBox 2471 SA 5001
Country 121239 0
Australia
Phone 121239 0
+61883021455
Fax 121239 0
Email 121239 0
[email protected]
Contact person for scientific queries
Name 121240 0
Kate Kennedy
Address 121240 0
UniSA City East Campus, Clinical & Health Sciences
Playford, GPOBox 2471 SA 5001
Country 121240 0
Australia
Phone 121240 0
+61883021536
Fax 121240 0
Email 121240 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
Due to Ethical considerations individual data will be deidentified and reported in aggregate.


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
No additional documents have been identified.