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Trial registered on ANZCTR


Registration number
ACTRN12618000390280
Ethics application status
Approved
Date submitted
6/12/2017
Date registered
15/03/2018
Date last updated
18/02/2019
Date data sharing statement initially provided
18/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating an enhanced care program (for You For Life Tapestry) for Australian residential aged care.
Scientific title
Evaluation of the 'for You For Life Tapestry' enhanced care program at residential aged care facilities in Australia.
Secondary ID [1] 293425 0
Nil known
Universal Trial Number (UTN)
U1111-1205-5613
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 305582 0
Residential Aged Care Communication 305583 0
Condition category
Condition code
Neurological 304812 304812 0 0
Dementias
Public Health 305594 305594 0 0
Health service research
Diet and Nutrition 305595 305595 0 0
Other diet and nutrition disorders
Injuries and Accidents 305596 305596 0 0
Other injuries and accidents
Mental Health 305597 305597 0 0
Depression
Neurological 305598 305598 0 0
Alzheimer's disease
Physical Medicine / Rehabilitation 305599 305599 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Evaluation of the Tapestry program at Royal Freemasons

The 'For You For Life Tapestry' program (short name Tapestry) is an enhanced model of care that predicts, tracks and coordinates a resident’s journey in aged care. This then facilitates and integrates the ongoing assessment and management of all the medical, physical, functional and emotional requirements of each resident from the moment they enter residential care, as well as throughout all stages of their subsequent care journey. This new model enables better administrative overview, promotes teamwork, and fosters closer collaboration with family. The program uses both existing and newly developed tools to enhance the approach to residential care. A key feature is a tool specifically designed for the program called a 'Transition Map', an information-rich yet simple tool to track and coordinate a resident’s journey in aged care.
Other components of the Tapestry program include the Cumulative Illness Rating Scale Geriatrics (CIRS-G, an existing scale), and resident goal care plans (developed specifically for the Tapestry program), as well as systems and policies to support the integration of the Tapestry program with existing care.
Prior to the trial commencement, focus groups will be run separately for each care facility to discuss the Tapestry Project and Transition Map. At each site a focus group for relatives and care staff will be run. Care staff focus groups will be further broken down into the different types of staff, i.e. Personal Care Workers, Registered Nurses/Case Managers, Enrolled Nurses, etc. Focus groups will only be run prior to data collection. At the beginning of the 12-month trial period, research assistants will approach all cognitively appropriate residents at each aged care facility. If a resident agrees to participate, they will complete an informed consent form, a Quality of Life scale, a Katz Activities of Daily Living Scale and a Standard Mini Mental State Examination. 24 randomly selected residents will also be ask to complete the Personhood “This is Me” Questionnaire. For residents who are unable to provide their own consent, next of kin will be asked to provide consent on behalf of the individual. These 4 measures will be repeated every 3 months for 12-months and will completed by the same research assistants, each assessment will take approximately 20-40 minutes. For non-English speaking residents, an interpreter will be arranged. Transition Maps will be completed by relatives and care staff about the resident. The Transition Map assesses a person’s overall health and determines what stage of health they are in and what care staff and family can expect to happen at this point. For example, if an individual in the care facility is palliative, the Transition Map would help to begin a conversation between staff and family members regarding treatment plans and care goals for the resident. The research assistants will not be involved in the Transition Map conversations. Transition Map discussions can be expected to range from 20minutes to 1 hour depending in the family and resident’s needs. Each facilities care staff will asked to complete a Staff Experience Questionnaire individually without the presence of research assistants. Staff will also be asked to complete a Personhood “This Is Me” Questionnaire in the presence of a research assistant. This will take approximately 20 minutes and will be conducted at the baseline, 6- months and 12-month’s time points. The Cumulative Illness Rating Scale will be completed about each resident by care staff. This will occur at the baseline, 3-months, 6-months, 9-months and 12-month time points.
The Tapestry program will be incorporated into existing Royal Freemasons care services at seven residential aged care facilities, and this trial is an evaluation of that program. Therefore the implementation of the Tapestry program will be conducted by Royal Freemasons aged care staff, whilst the National Ageing Research Institute will conduct the evaluation of the Tapestry program. This trial will evaluate the impact of the program in improving resident related outcomes (such as resident quality of life), and family-staff communication.
Intervention code [1] 300255 0
Treatment: Other
Comparator / control treatment
No control treatment group - this study is a (semi) longitudinal study that involves repeated observations of the same variables over 12 months, Comparisons will be made based on data collected at four different time points.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304023 0
Changes in communication between relatives/staff - This will be assessed through the use of the Transition Map and Experience Questionnaires that will be given to staff and relatives.

The Transition Map has been trial in a pilot study previously. This was published but created for the sole purpose of being implemented at "The Royal Freemasons" residential aged care facilities. This article is called "Testing the reliability and validity of a Transition Map for older adults in long term care settings". Full reference: Savvas, S. M., Gibson, S. J., Rizakis, P., Vaughan, M. P., & Scherer, S. C. (2017). Testing the reliability and validity of a Transition Map for older adults in long term care settings. Geriatric Nursing, 38(6), 551-558.

The Consumer Experience Questionnaires are validated questionnaires developed by LaTrobe University, although have only had pilot testing. The results of this pilot study have been published as Wells, Y., Herd, A., & Fetherstonhaugh, D. (2017). Developing a consumer experience report: Pilot stage. Melbourne: Australian Institute for Primary Care & Ageing, La Trobe University.
Timepoint [1] 304023 0
Baseline (enrollment to the study), 6-months, 12-months (end-point)

The Tapestry Map and the Experience Questionnaire will be applied at each time point for the duration for the research.
Primary outcome [2] 304026 0
Quality of Life : Alzheimer's Disease - A validated scale questionnaire where a participant rates their current quality of life of 15 areas, from poor to excellent (poor, fair, good and excellent). Each question asked is based on how the participant feels at the present time. Each time point will be compared to the others.
Timepoint [2] 304026 0
Baseline, 3-months, 6-months, 9 -months and 12-months (end point)
Primary outcome [3] 304718 0
Changes in care delivery at Royal Freemasons Aged Care Facilities - Through the implementation of Personhood "This Is Me" Questionnaire, staff have the opportunity to change approaches to each resident by getting to know their likes, dislikes, personality etc. better.

The Personhood "This Is Me" Questionnaire or TIME, is a validated questionnaire published by Pan, J. L., Chochinov, H., Thompson, G., & McClement, S. (2016). The TIME Questionnaire: A tool for eliciting personhood and enhancing dignity in nursing homes. Geriatric Nursing, 37(4), 273-277.

It was created for residential aged care facility clients and is used as a means to gather information that is important to the residents, such as what are your values, your relations, your life time achievements, and your likes and dislikes. It is intended to be used for gathering information about new residents to give them the best care and transition in to residential aged care. During this study, it will be used on residents and staff. Staff will answer questions about specific residents, and these answers will be compared to answers that residents give about themselves.

Baseline will be prior to the Transition Map's implementation and all following time points will be compared to baseline and changes that have been made. Such changes may include improve communication with patient who may receive better care, improved communication between family and resident, individually tailored food choices, etc.
Timepoint [3] 304718 0
Baseline (primary time point), 3-months, 6-months, 9-months and 12-months (end time point).

Baseline - pre-Transition Map implementation.
3-,6-,9-,12-months - Transition Map has been implemented and assessment of changes in communication between staff and resident.
Secondary outcome [1] 340735 0
Change in Non-beneficial treatments - Changes to medication charted will be assessed by obtaining each residents medication chart and determining if medications have been changed and if they were of little to no benefit previously. This will be determined by experienced medical doctors on the project.
Timepoint [1] 340735 0
Baseline, 12-months (end time point)
Secondary outcome [2] 342928 0
Change in Hospital Admissions - By using the "Resident Movement List" and each residents notes, each residents hospital admissions can be tracked. Hospital admissions prior to the commencement to the research project will not be included
Timepoint [2] 342928 0
Assessed at Baseline (primary time point), 3-months, 6-months, 9-months and 12-months (end time point).
Secondary outcome [3] 342929 0
Changes in resident goal plans - using the resident goals plans created between staff and residents, goals can be tailored to each resident in an orderly and realistic manner. Changes in resident goal plans will be assessed through interviews with residents to determine if the resident feels the goals have or have not been achieved.
Timepoint [3] 342929 0
Baseline and 12-months (end time point)
Secondary outcome [4] 342930 0
Relative Satisfaction with Royal Freemasons care and communication - Relatives satisfaction with Royal Freemasons and care staff will be determined by completing "Relative Experience Questionnaires" to evaluate care.

The Relative Experience Questionnaires are a derivative of the Consumer Experience Questionnaires created by LaTrobe University. This version, tailored to the relative has been created specifically for this study
Timepoint [4] 342930 0
Baseline (primary time point), 6-months, 12-months (end time point)
Secondary outcome [5] 343648 0
(Primary)
Changes to the Standard Mini Mental State Examination - This is a validated mental state examination that is widely accepted and used around the world. Participants will conduct this examination at all time points and these will be compared to baseline and/or 12-months (endpoint).
Timepoint [5] 343648 0
Baseline (primary time point), 3-months, 6-months, 9-months and 12-months (end time point).
Secondary outcome [6] 343649 0
(Primary)
Changes to Katz Index of Independence in Activities of Daily Living (Katz ADL's) - This scale is a validated tool that assess changes to an individuals ability to perform Activities of Daily Living independently or with assistance. Changes in this scale are determined quantitatively where a resident will receive a score of 1 for independence and a 0 for dependence. Each time point will be compared to baseline and/or end point (12-months)
Timepoint [6] 343649 0
Baseline (primary time point), 3-months, 6-months, 9-months and 12-months (end time point).

Eligibility
Key inclusion criteria
*Resident at one of the participating Royal Freemasons residential aged care facilities in Victoria.
*Relative of a resident at one of the participating Royal Freemasons residential aged care facilities in Victoria (must be above 18 years old)
*Staff currently employed by Royal Freemasons at one of the key study facilities.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Residents under 18 years old in the aged care facility
Relatives under 18 years old
Residents in a transition care program, or otherwise expected to move out of the site within two months of baseline measures, will be excluded from participating.

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data collected in each timeline will be analysed by SPSS (descriptive analysis). SPSS analysis will be also conducted to produce comparisons of the variables throughout different time phases.
The number of participants was determined based on the number of residents at Royals Freemasons Facilities and based on previous research using Royal Freemasons Aged Care Facilities, we determined a 70% participation rate.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
24/11/2017
Date of last participant enrolment
Anticipated
31/05/2018
Actual
27/08/2018
Date of last data collection
Anticipated
29/08/2019
Actual
Sample size
Target
645
Accrual to date
Final
645
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 298050 0
Government body
Name [1] 298050 0
Department of Health, Dementia and Aged Care services
Country [1] 298050 0
Australia
Primary sponsor type
Other
Name
National Ageing Research Institute
Address
34-52 Poplar Road
Parkville, VIC, 3052
Country
Australia
Secondary sponsor category [1] 297127 0
None
Name [1] 297127 0
None
Address [1] 297127 0
None
Country [1] 297127 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299072 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 299072 0
Ethics committee country [1] 299072 0
Australia
Date submitted for ethics approval [1] 299072 0
20/09/2017
Approval date [1] 299072 0
10/10/2017
Ethics approval number [1] 299072 0
HREC/17/MH/296

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

Contacts
Principal investigator
Name 79198 0
Dr Steven Savvas
Address 79198 0
National Ageing Research Institute
34-54 Poplar Road,
Parkville, VIC, 3052
Country 79198 0
Australia
Phone 79198 0
+61 3 8387 2465
Fax 79198 0
Email 79198 0
s.savvas@nari.edu.au
Contact person for public queries
Name 79199 0
Maho Omori
Address 79199 0
National Ageing Research Institute
34-54 Poplar Street, Parkville, VIC, 3052
Country 79199 0
Australia
Phone 79199 0
+61 3 8387 2657
Fax 79199 0
Email 79199 0
m.omori@nari.edu.au
Contact person for scientific queries
Name 79200 0
Steven Savvas
Address 79200 0
National Ageing Research Institute
34-54 Poplar Road, Parkville, VIC, 3052
Country 79200 0
Australia
Phone 79200 0
+61 3 8387 2465
Fax 79200 0
Email 79200 0
s.savvas@nari.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD contains confidential privacy information and medical record, and can be only accessed by the research team.


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.