Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Date results information 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.
Query!
Scientific title
Evaluation of the 'for You For Life Tapestry' enhanced care program at residential aged care facilities in Australia.
Query!
Secondary ID [1]
293425
0
Nil known
Query!
Universal Trial Number (UTN)
U1111-1205-5613
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Dementia
305582
0
Query!
Residential Aged Care Communication
305583
0
Query!
Condition category
Condition code
Neurological
304812
304812
0
0
Query!
Dementias
Query!
Public Health
305594
305594
0
0
Query!
Health service research
Query!
Diet and Nutrition
305595
305595
0
0
Query!
Other diet and nutrition disorders
Query!
Injuries and Accidents
305596
305596
0
0
Query!
Other injuries and accidents
Query!
Mental Health
305597
305597
0
0
Query!
Depression
Query!
Neurological
305598
305598
0
0
Query!
Alzheimer's disease
Query!
Physical Medicine / Rehabilitation
305599
305599
0
0
Query!
Other physical medicine / rehabilitation
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
300255
0
Treatment: Other
Query!
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.
Query!
Control group
Uncontrolled
Query!
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.
Query!
Assessment method [1]
304023
0
Query!
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.
Query!
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.
Query!
Assessment method [2]
304026
0
Query!
Timepoint [2]
304026
0
Baseline, 3-months, 6-months, 9 -months and 12-months (end point)
Query!
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.
Query!
Assessment method [3]
304718
0
Query!
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.
Query!
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.
Query!
Assessment method [1]
340735
0
Query!
Timepoint [1]
340735
0
Baseline, 12-months (end time point)
Query!
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
Query!
Assessment method [2]
342928
0
Query!
Timepoint [2]
342928
0
Assessed at Baseline (primary time point), 3-months, 6-months, 9-months and 12-months (end time point).
Query!
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.
Query!
Assessment method [3]
342929
0
Query!
Timepoint [3]
342929
0
Baseline and 12-months (end time point)
Query!
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
Query!
Assessment method [4]
342930
0
Query!
Timepoint [4]
342930
0
Baseline (primary time point), 6-months, 12-months (end time point)
Query!
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).
Query!
Assessment method [5]
343648
0
Query!
Timepoint [5]
343648
0
Baseline (primary time point), 3-months, 6-months, 9-months and 12-months (end time point).
Query!
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)
Query!
Assessment method [6]
343649
0
Query!
Timepoint [6]
343649
0
Baseline (primary time point), 3-months, 6-months, 9-months and 12-months (end time point).
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
N/A
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
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.
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
24/11/2017
Query!
Date of last participant enrolment
Anticipated
31/05/2018
Query!
Actual
27/08/2018
Query!
Date of last data collection
Anticipated
29/08/2019
Query!
Actual
Query!
Sample size
Target
645
Query!
Accrual to date
Query!
Final
645
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Funding & Sponsors
Funding source category [1]
298050
0
Government body
Query!
Name [1]
298050
0
Department of Health, Dementia and Aged Care services
Query!
Address [1]
298050
0
Department of Health
GPO Box 9848,
Canberra ACT 2601, Australia
Query!
Country [1]
298050
0
Australia
Query!
Primary sponsor type
Other
Query!
Name
National Ageing Research Institute
Query!
Address
34-52 Poplar Road
Parkville, VIC, 3052
Query!
Country
Australia
Query!
Secondary sponsor category [1]
297127
0
None
Query!
Name [1]
297127
0
None
Query!
Address [1]
297127
0
None
Query!
Country [1]
297127
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
299072
0
Melbourne Health Human Research Ethics Committee
Query!
Ethics committee address [1]
299072
0
Level 2
South West
300 Grattan Street
Parkville, VIC, 3052
Query!
Ethics committee country [1]
299072
0
Australia
Query!
Date submitted for ethics approval [1]
299072
0
20/09/2017
Query!
Approval date [1]
299072
0
10/10/2017
Query!
Ethics approval number [1]
299072
0
HREC/17/MH/296
Query!
Summary
Brief summary
Background:
Royal Freemasons has developed an enhanced care program that emphasises the ‘transitions’ that residents experience in their journey in residential aged care. This program is called ‘For You For Life Tapestry’ (or just ‘Tapestry’). Elements of this program were evaluated in a pilot case-control study (Melb Health Negligible Risk Research Approved Project QA2014215), with positive outcomes. Royal Freemasons is now expanding this project by integrating the Tapestry program into existing routine care at multiple Royal Freemasons aged care facilities in Victoria, as part of a quality improvement service. Royal Freemasons has partnered with the National Ageing Research Institute (NARI) to assist with the quality assurance and research evaluation of this Tapestry program.
Rationale for the study:
Elements of the Tapestry program have been successfully piloted and evaluated. However a number of limitations warrant a larger more comprehensive evaluation. The pilot was short in length and small in sample size. Residents in the pilot were not systematically followed at regular time points over a sufficiently long time frame. The pilot also did not evaluate how the program impacted the families of residents.
This two year project (ending June 2019) will address the limitations of the pilot by implementing and evaluating the Tapestry program in seven urban and regional Victorian residential aged care facilities. The implementation of the program includes the Transition Map scale (developed for the Tapestry program), Cumulative Illness Rating Scale Geriatrics (CIRS-G, an existing scale), and a resident goal care plan (developed for the Tapestry program), as well as systems and policies to support the integration of the Tapestry program with existing care. NARI will evaluate outcome measures of the Tapestry program integration that is being implemented by Royal Freemasons.
This research study will evaluate the Tapestry program at seven Royal Freemasons residential aged care facilities. This program aims to better equip RESIDENTS and RELATIVES to make informed choices and timely plans, realistic resident goals, and accept that some treatments may be non-beneficial and should be avoided.
Participating RESIDENTS will be regularly evaluated on a number of outcome measures for one year. Outcomes include quality of life, functional status, health and medical outcomes (including number of hospital admissions and number of potentially non-beneficial treatments), resident goal plans, and RELATIVE satisfaction with care and communication.
After the implementation of the program, the primary hypotheses are:
(1) improved RESIDENT quality of life, and appropriate and achievable goals at 12 months,
(2) decreased RESIDENT hospital admissions and reduced non-beneficial treatments at 12 months,
(3) RELATIVES report improved satisfaction with care and better communication
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
The following paper describes the development of the Transition Map scale, a central component of the 'For you For Life Tapestry' program.
Citation: Savvas, S. M., S. J. Gibson, et al. (2017). "Testing the reliability and validity of a Transition Map for older adults in long term care settings." Geriatric Nursing.
Query!
Contacts
Principal investigator
Name
79198
0
Dr Steven Savvas
Query!
Address
79198
0
National Ageing Research Institute
34-54 Poplar Road,
Parkville, VIC, 3052
Query!
Country
79198
0
Australia
Query!
Phone
79198
0
+61 3 8387 2465
Query!
Fax
79198
0
Query!
Email
79198
0
[email protected]
Query!
Contact person for public queries
Name
79199
0
Dr Maho Omori
Query!
Address
79199
0
National Ageing Research Institute
34-54 Poplar Street, Parkville, VIC, 3052
Query!
Country
79199
0
Australia
Query!
Phone
79199
0
+61 3 8387 2657
Query!
Fax
79199
0
Query!
Email
79199
0
[email protected]
Query!
Contact person for scientific queries
Name
79200
0
Dr Steven Savvas
Query!
Address
79200
0
National Ageing Research Institute
34-54 Poplar Road, Parkville, VIC, 3052
Query!
Country
79200
0
Australia
Query!
Phone
79200
0
+61 3 8387 2465
Query!
Fax
79200
0
Query!
Email
79200
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
IPD contains confidential privacy information and medical record, and can be only accessed by the research team.
Query!
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.
Download to PDF