Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000268246
Ethics application status
Approved
Date submitted
5/02/2018
Date registered
21/02/2018
Date last updated
30/01/2019
Date data sharing statement initially provided
30/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
'Agents of Change': Improving post diagnosis care for people with dementia and their carers through the establishment of a National Quality Collaborative to implement guideline recommendations
Scientific title
'Agents of Change': Improving post diagnosis care for people with dementia and their carers through the establishment of a National Quality Collaborative to implement guideline recommendations
Secondary ID [1] 293493 0
None
Universal Trial Number (UTN)
U1111-1208-9029
Trial acronym
AOC
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Dementia
 306111 0
Cognitive impairment
 306113 0
Alzheimer's disease
 306114 0
Vascular Dementia
 306115 0
Lewy body disease
 306116 0
Frontotemporal dementia
 306117 0
Functional decline 306118 0
Condition category
Condition code
Neurological 305238 305238 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Online delivery of a training course for health professionals. Health professionals working in dementia care will act as implementation clinicians in the AOC project. They will be supported and trained to develop and then enact an implementation plan to improve the implementation of three key recommendations from the Clinical Practice Guidelines for Dementia in Australia:
• Occupational therapy - people with dementia living in the community should be offered occupational therapy (reflecting evidence based programs)
• Exercise - people with dementia should strongly be encouraged to exercise
• Carers - carers and family of people with dementia should be offered respite and have access to programs to support and optimise their ability to provide care for the person with dementia
Implementation clinicians will enact their plan within their workplace within the resources available to them, and have ongoing meetings and support with their collaborative and experts.
METHOD: Implementation clinicians will be recruited via advertising. Suitable clinicians will complete online training program with a time commitment of approximately 2 hours a week for 6 weeks. The research team will develop the online learning program with the help of consumer advisers and clinical experts in the field. Clinical experts and the research team include occupational therapists, exercise physiologist, psychologist, international business manager, and academics, including research fellows and senior research fellows with an extensive experience in aged care and dementia research. Consumer advisers are person with dementia and the carer who both have been previously involved in research and advocacy in dementia. Implementation clinicians will participate in this online learning program where they will be trained in practical implementation to gradually develop a site specific implementation plan. They will have a support from the research team and an implementation expert.
The implementation clinicians will develop their own implementation plans iteratively and interactively during the online training and will be enacted within their own site using 'plan-do-study-act' methodology. The aim of the intervention is to support the implementation clinicians to become 'agents of change' and enable people living with dementia and their formal carers to be routinely provided with best practice care.
The outcomes measured are:
• Primary outcome: the number of people living with dementia receiving care which meets the following criteria: - occupational therapy
- exercise and
- informal carers
as described by treating clinician.
• Secondary outcomes: evaluation outcomes including acceptability, feasibility, adherence to the guideline recommendations, consumer reported outcomes and experience and skills and knowledge acquired by clinicians in quality improvement.
MATERIALS: Implementation clinicians will develop their own theory-informed implementation plan using plan-do-study-act (PDSA) cycles. They will learn about practical application of Organisational Readiness and COM-B and draw on these models as they form their implementation plan tailored to their recommendation of interest within their own sites. In addition to online training and tools they will have regular online communication and teleconferences with their peers to support and learn from each other. It is anticipated that implementation clinicians will have teleconferences with their peers once per month, between 30 and 60 minutes for the duration of the project (18 months). They will also have the opportunity to have a written communication with their peers on MOOC (online learning platform) that they will organise at their own discretion. In addition researchers will also create a networking group on Yammer or similar social networking service to enable clinicians to have ongoing communications with each other (at their own discretion) for the entire duration of the project (9 months prior to- and 9 months post the intervention).
This study incorporates 18 months of data collection, 9 months pre intervention and 9 months post intervention.
INTERVENTIONIST: The interventionist is a registered health professional (as described above) who will receive the training and get support to develop its own theory informed implementation plan aiming to improve access to physical activity, occupational therapy, and respite and carer support for people with dementia and their cares.

Intervention code [1] 299994 0
Behaviour
Intervention code [2] 299995 0
Rehabilitation
Intervention code [3] 299996 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304393 0
The number of people living with dementia receiving the care which meets the following criteria: - occupational therapy - exercise - informal carers as described by treating clinicians. This is a composite outcome. This outcome will be assessed using: - Clinician checklists: Clinicians will complete checklists for each person with dementia and/or carer (dyad) they see, with details about the assessment and treatment/recommendations provided. Carer phone interview: Each month, 30 dyads will be randomly chosen from among those consenting to a phone interview. The carer of the selected dyads will be contacted and interviewed for approximately 10 minutes. Interview questions will assess the recollection of care provided, satisfaction with care, quality of life, and resource use. Study specific questionnaire detailing content of practice will be used. Dyads will also be asked for consent to repeat the call approximately 8 weeks later. The later call will include questions about quality of life only, to assess for sustained impacts.
Timepoint [1] 304393 0
Monthly data collection (time series) for 18 months, 9 months prior to and 9 months following the intervention.
Secondary outcome [1] 341801 0
Feasibility: The number of sites joining and remaining in the scheme for the duration of the project
Timepoint [1] 341801 0
Monthly data collection (time series) 9 months prior and 9 months following the intervention.
Secondary outcome [2] 341802 0
Acceptability: The information about the clinician's participation in the program and acceptability of the intervention and process and barriers measured via interviews with implementation clinicians using pre and post intervention.
Timepoint [2] 341802 0
Two interviews with implementation clinicians, one at month 1 prior to the intervention and 1 at month 18 (9 months following the intervention).
Secondary outcome [3] 341803 0
Adherence to the guideline recommendations and report from people living with dementia and their carers. This refers to the adherence from the perspective of carers and it will be assessed using filed notes, dyad phone interviews and clinicians checklists re care provided.
Timepoint [3] 341803 0
Monthly data collection, 9 months pre intervention (assessment of adherence to the current practices) and 9 months post intervention (assessment of adherence to the guideline recommendations)
Secondary outcome [4] 341804 0
Consumer reported experience to assess the satisfaction with the service measured via satisfaction and care questionnaire taken and adapted from Short-Form Patient satisfaction Questionnaire (PSQ-18), RAND Health.
Timepoint [4] 341804 0
Three months following the implementation of the intervention and monthly thereafter for 6 months.
Secondary outcome [5] 341805 0
Consumer reported outcomes to determine an impact on outcome for people with dementia or their carer measured via DEMQOL or Zarit Burden Inventory
Timepoint [5] 341805 0
Three months following the implementation of the intervention and monthly thereafter for 6 months.
Secondary outcome [6] 341806 0
Skills and knowledge acquired by the implementation clinicians in quality improvement measured using QIKAT-R tool. This is a composite outcome.
Timepoint [6] 341806 0
Two interviews with implementation clinicians one at month 1 prior to the intervention and 1 at month 18 (9 months following the intervention).

Eligibility
Key inclusion criteria
Health professionals across Australia ( e.g. general practitioners, nurses, social workers, occupational therapists, physiotherapists, psychologists) who regularly provide services to people with dementia, and who have some influence in their workplace to affect change.
People with dementia living in the community.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with dementia living in residential aged care facilities will be excluded.
Failure to meet the above criteria.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Process evaluation design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This project uses an interrupted time series design with monthly data collection over 18 months. Adherence before and after the implementation will be determined from the perspective of the person with dementia, carer and health professional. Segmented regression analysis methods with autoregressive error models that account for correlations of the data across the time points will be used.
Qualitative data will be analysed using simple thematic analysis and coding conducted by two members of the research team

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
13/12/2017
Date of last participant enrolment
Anticipated
31/03/2018
Actual
4/06/2018
Date of last data collection
Anticipated
31/03/2019
Actual
Sample size
Target
30
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 9717 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 18492 0
5042 - Flinders University

Funding & Sponsors
Funding source category [1] 298111 0
Government body
Name [1] 298111 0
NHMRC Cognitive Decline Partnership Centre
Country [1] 298111 0
Australia
Funding source category [2] 298358 0
Government body
Name [2] 298358 0
NHMRC Boosting Dementia Research Grants
Country [2] 298358 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO BOX 2100
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 297190 0
None
Name [1] 297190 0
na
Address [1] 297190 0
na
Country [1] 297190 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299130 0
The Southers Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 299130 0
Ethics committee country [1] 299130 0
Australia
Date submitted for ethics approval [1] 299130 0
20/04/2017
Approval date [1] 299130 0
08/11/2017
Ethics approval number [1] 299130 0
HREC/17/SAC/88

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

Contacts
Principal investigator
Name 79402 0
Dr Kate Laver
Address 79402 0
Flinders University
Department of Rehabilitation, Aged and Extended Care
College of Medicine and Public Health
GPO Box 2100
Adelaide 5001
South Australia
Country 79402 0
Australia
Phone 79402 0
+61 8 7221 8335
Fax 79402 0
Email 79402 0
[email protected]
Contact person for public queries
Name 79403 0
Monica Cations
Address 79403 0
Flinders University
Department of Rehabilitation, Aged and Extended Care
College of Medicine and Public Health
GPO Box 2100
Adelaide 5001
South Australia
Country 79403 0
Australia
Phone 79403 0
+61 8 7221 8338
Fax 79403 0
Email 79403 0
[email protected]
Contact person for scientific queries
Name 79404 0
Kate Laver
Address 79404 0
Flinders University
Department of Rehabilitation, Aged and Extended Care
College of Medicine and Public Health
GPO Box 2100
Adelaide 5001
South Australia
Country 79404 0
Australia
Phone 79404 0
+61 8 7221 8335
Fax 79404 0
Email 79404 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 confidentiality reasons individual data will not be available publicly. Updates of the project to HREC and funding bodies will use aggregate data.


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
EmbaseAgents of change: establishing quality improvement collaboratives to improve adherence to Australian clinical guidelines for dementia care.2018https://dx.doi.org/10.1186/s13012-018-0820-z
EmbasePost-diagnostic allied health interventions for people with dementia in Australia: a spotlight on current practice.2019https://dx.doi.org/10.1186/s13104-019-4588-2
EmbaseHow, why and under what circumstances does a quality improvement collaborative build knowledge and skills in clinicians working with people with dementia? A realist informed process evaluation.2021https://dx.doi.org/10.1136/bmjoq-2020-001147
N.B. These documents automatically identified may not have been verified by the study sponsor.