Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000779279
Ethics application status
Approved
Date submitted
24/04/2018
Date registered
9/05/2018
Date last updated
4/03/2020
Date data sharing statement initially provided
2/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Consumer Directed Care in residential aged care: Transforming care staff practices through the Resident at the Centre of Care (RCC) training program
Scientific title
Resident at the Centre of Care: A Consumer Directed Care training program from residential aged care staff to promote resident autonomy and improve quality of life.
Secondary ID [1] 294653 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Residential aged care 307498 0
Quality of life 307499 0
Staff wellbeing 307503 0
Condition category
Condition code
Public Health 306583 306583 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Resident at the Centre of Care (RCC) program is designed to increase staff awareness and understanding of Consumer Directed Care (CDC), educate staff on the use of a Resident Care Form to obtain resident choices on care, empower leaders to address the organisational barriers to implementing CDC and support staff in this implementation of the RCC program. The training program will be delivered by a member of the research team with experience in facilitation in the aged care sector. The five sessions are spread over 9-weeks (1 week between sessions except 4 weeks between sessions 3 and 4), with each training session will run for approximately 2-hours during work time at the Residential Aged Care Facility (RACF).
Session 1 - Transformational Leadership: This session is for senior staff only. It will provide an overview of RCC program and CDC in residential aged care. It will also examine the role of senior staff during the RCC program and throughout the transition to a CDC model of care. Senior staff will also be provided with an overview of the key skills associated with a Transformational Leadership style and its importance in promoting successful change.
Session 2 – Barriers and Enablers to CDC: This and all subsequent sessions will be attended by all staff participants. Detail about the RCC program and CDC will be provided for the benefit of general staff. Staff will also be encourage to consider the barriers and enablers to implementing CDC specific to their facility. This discussion will be supplemented by an overview of the organisational factors associated with successful and sustainable change.
Session 3 - Communication and Autonomy: Addresses the integral role of staff and resident collaboration and communication to CDC. Example approaches to eliciting resident choice and promoting control will be examined and practised. The session also provides staff with an opportunity to practise minimising the earlier identified barriers and fostering the enablers of successful CDC implementation.
Session 4 – CDC Plan outline: Following a 4-week break, staff will review their experience of working with residents to determine their care and leisure preferences. Staff will use this experience to guide the development of clear processes for collecting, recording and implementing resident preferences. The session ends with staff developing an outline of the essential elements of the CDC Implementation Plan for their facility.
Session 5 – CDC Implementation Plan: This session asks staff to refine the CDC Plan outline created in Session 4. By the end of the session, staff will have created a detailed CDC Implementation Plan to guide them through the transition to a CDC model of care. This plan will include milestones with specific achievements at various time points (e.g. in the next month, in 3 months, and so on). Staff will also consider approaches to ensuring they stay on track with their plan and how to address newly identified barriers in the future.

Procedure
The RCC program is a face-to-face group training intervention that will be implemented and evaluated in a three-arm cluster RCT research design. A total of 39 residential aged care facilities (RACFs) will be randomly allocated into one of the three conditions (13 sites in each) – “training + support”, “training only” or “care as usual”.
Training + support: Implementation of the 5-session RCC program among managers, Registered Nurses, Personal Care Attendants, lifestyle, kitchen and other support staff. Additional organisational support will be provided for one day per week for four weeks between Session 3 and 4, and a further one day per week for 12 weeks following Session 5. The research personnel providing support will work with staff to assist them to create the climate in which CDC can prosper and to ensure the embedding and sustainability of the leadership and organisational changes from the RCC program.
Training only: Implementation of the RCC Program among managers, RNs and PCAs as well as lifestyle and kitchen staff; no additional organisational support.

Adherence to the intervention will be monitored by the Project Coordinator via regular supervision with the training facilitator (for session preparation and debrief). The effectiveness of the RCC Program in improving resident QoL and staff job satisfaction and reducing staff stress and turnover will be determined through a timeline of evaluations planned for pre/post-intervention and at 3, 6 and 12 months follow up. We will assess whether RCC training results in effective CDC implementation (comparison of “training + support” and “training only” with the “care as usual” condition) and if provision of additional organisational support results in better sustainability of CDC implementation (comparisons of “training + support” and “training only”). Even if some aspects of CDC are currently being adopted in some facilities, we would expect our comprehensive RCC program (“training + support” and “training only” conditions) to effect greater changes in resident and staff measures compared to “care as usual” (control condition) as well as testing the value of additional organisational support.

Participants
The participants will be aged care residents and staff recruited from RACFs managed by our partner organisations. Informed consent will be obtained from facility managers, staff, and the residents themselves, or if they are unable to provide consent because of communication or cognitive difficulties, from their family or guardian. All data will be de-identified when they are coded and questionnaires will be kept confidential to the researchers. Every resident at each participating site who meets the following inclusion criteria will be invited to take part: Residents older than 65 years and living in the RACF for more than three months. Exclusion criteria will be: acute medical illness likely to compromise participation in the program; inability to effectively communicate due to no English language or severe dementia (PAS score = 16 or higher). Based on our previous work with RACFs, we expect an average of 20 residents per facility to be eligible and willing to take part in the study.
Across the 39 sites, we expect to recruit a total of 833 staff (an average of 21-22 staff per facility; sample size calculation is detailed below). This will include approximately equal numbers of senior staff (e.g., facility managers, RNs) and support staff (personal care attendants, lifestyle and kitchen staff). To facilitate knowledge translation, staff in each of the 26 sites randomised to the intervention groups (Conditions 1 and 2) will be trained to work with the remaining staff to promote the philosophy of CDC and in organisational procedures for adopting the CDC approach. Session 1 of the RCC program will be for senior staff only, while Session 2-4 are for all staff.
Intervention code [1] 300952 0
Behaviour
Comparator / control treatment
This trial includes a control (care as usual) group. The control sites will not receive the RCC training program but will complete all outcome measures at time points equivalent to the intervention sites (i.e. baseline, post-training, 3, 6 and 12 month follow-up).
Control group
Active

Outcomes
Primary outcome [1] 305583 0
Resident quality of life as assessed by the Quality of Life-AD (QoL-AD; Edelman et al., 2005), aged care adaptation. This measure was designed for participants diagnosed with Alzeihmer's Disease but is also suitable for use with "healthy" participants. In this study, this measure will be used for all resident participants, regardless of level of cognitive function.
Timepoint [1] 305583 0
Baseline (i.e. pre-intervention), 3 months post-intervention, 6 months post-intervention [primary timepoint], and 12 months post-intervention.
Secondary outcome [1] 345820 0
Changes in staff leadership style (Multifactor Leadership Questionnaire; Bass & Avolio, 1989)
Timepoint [1] 345820 0
Baseline (i.e. pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 12 months post-intervention.
Secondary outcome [2] 345821 0
RACF staff job satisfaction (Global workplace scale; Firth et al, 2004)
Timepoint [2] 345821 0
Baseline (i.e. pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 12 months post-intervention.
Secondary outcome [3] 345822 0
RACF staff intention to quit (Global workplace scale; Firth et al, 2004)
Timepoint [3] 345822 0
Baseline (i.e. pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 12 months post-intervention.
Secondary outcome [4] 345823 0
Working alliance with residents, as perceived by staff (STAR-C; McGuire-Sneickus et al., 2007)
Timepoint [4] 345823 0
Baseline (i.e. pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 12 months post-intervention.
Secondary outcome [5] 345826 0
Frequency of consumer-directed care staff practices (Individualized Care Scale; Chappell et al., 2007)
Timepoint [5] 345826 0
Baseline (i.e. pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 12 months post-intervention.
Secondary outcome [6] 345827 0
RACF staff work-role stress (Strain in Dementia Care Scale; Edberg et al., 2015)
Timepoint [6] 345827 0
Baseline (i.e. pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 12 months post-intervention.
Secondary outcome [7] 345828 0
Aged care facility consumer-directed care practices using an adaptation of the Person-Centred Care Assessment Tool (P-CAT; Edvardsson et al, 2010).
Timepoint [7] 345828 0
Baseline (i.e. pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 12 months post-intervention.
Secondary outcome [8] 345829 0
Staff perceptions of organisational climate using the Organisational Climate Questionnaire (OCQ; Koys & DeCotiis, 1991)
Timepoint [8] 345829 0
Baseline (i.e. pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 12 months post-intervention.

Eligibility
Key inclusion criteria
Resident participants: older than 65 years and has lived in the RACF for more than three months.

Staff participants: all staff employed to work at the RACF.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Residents: acute medical illness likely to compromise participation in the program; inability to effectively communicate due to no English language or severe dementia (PAS score = 16 or higher)

Staff: staff contracted to work in the RACF (i.e. self-employed or employed by another organisation).

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)
A member of the team who is based off-site will compile a computer-generated randomisation schedule for each cluster of 3 facilities, randomly allocating sites into either the "training + support", "training only" or "care as usual" condition.
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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary analyses will be on an intention to treat basis, with supplementary ‘per protocol’ analyses (at least 75% of staff enrolled in the study completing at least 75% of training sessions). To account for the within-facility clustering and repeated assessments of staff and residents, differences in the outcomes of the participants will be compared with multilevel linear (or generalised where appropriate) regression modelling. For each outcome, a separate three-level regression model will be specified, with repeated measurements as level 1, individuals as level 2, and facility as level 3. The regression models will include Condition allocation, assessment time, and Condition by time interaction as predictors and baseline measurements and level of CDC implementation at baseline as covariates. Facilities will be modelled as random effects with remaining variables modelled as fixed effects. Missing data will be handled with conditional maximum likelihood estimation. The impact of possible non-random attrition will be explored with simulation analyses.

Sample size. Informed by the results of our earlier NHMRC-funded RCT (APP1042156) our study is designed to detect a moderately small difference d=0.35 between the RCC plus organisational support and control Condition in QoL of residents at 6-months follow up (primary outcome) and in staff outcomes post-intervention (secondary outcomes). We selected 6-months follow up as our primary endpoint for residents’ QoL because we expect a gradual and continuing change in this outcome as a result of changing practice. Allowing for 80% power, 5% Type I error rate (2-tailed), intra-class correlation of 0.02 for the within-facility clustering, and 25% (residents) and 33% (staff) attrition over time, we will need to randomise at least 744 residents (248 per Condition) and 833 staff (278 per Condition). Based on our previous work in the residential aged care setting, we expect an average recruitment of 20 residents and 22 staff per site. Hence, 39 aged care facilities will need to be enrolled into the study (13 for each arm of the RCT).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
30/05/2018
Actual
28/05/2018
Date of last participant enrolment
Anticipated
27/05/2019
Actual
14/06/2019
Date of last data collection
Anticipated
30/06/2020
Actual
Sample size
Target
1577
Accrual to date
Final
1326
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 299267 0
Government body
Name [1] 299267 0
National Health and Medical Research Council (NHMRC)
Country [1] 299267 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
John Street, Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 298574 0
None
Name [1] 298574 0
Address [1] 298574 0
Country [1] 298574 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300182 0
Swinburne Human Research Ethics Committee
Ethics committee address [1] 300182 0
Ethics committee country [1] 300182 0
Australia
Date submitted for ethics approval [1] 300182 0
26/02/2018
Approval date [1] 300182 0
01/03/2018
Ethics approval number [1] 300182 0
SHR Project 2018/070

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

Contacts
Principal investigator
Name 82822 0
Prof Marita McCabe
Address 82822 0
Swinburne University
H31 PO Box 218, Hawthorn VIC 3122
Country 82822 0
Australia
Phone 82822 0
+61 3 9214 5123
Fax 82822 0
Email 82822 0
[email protected]
Contact person for public queries
Name 82823 0
Marita McCabe
Address 82823 0
Swinburne University
H31 PO Box 218, Hawthorn VIC 3122
Country 82823 0
Australia
Phone 82823 0
+61 3 9214 5123
Fax 82823 0
Email 82823 0
[email protected]
Contact person for scientific queries
Name 82824 0
Marita McCabe
Address 82824 0
Swinburne University
H31 PO Box 218, Hawthorn VIC 3122
Country 82824 0
Australia
Phone 82824 0
+61 3 9214 5123
Fax 82824 0
Email 82824 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
IPD will not be shared to ensure that participant anonymity and confidentiality is preserved.


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
SourceTitleYear of PublicationDOI
EmbaseA randomized controlled trial to evaluate the effectiveness of a staff training program to implement consumer directed care on resident quality of life in residential aged care.2018https://dx.doi.org/10.1186/s12877-018-0966-1
N.B. These documents automatically identified may not have been verified by the study sponsor.