Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001026617
Ethics application status
Approved
Date submitted
7/07/2023
Date registered
21/09/2023
Date last updated
21/09/2023
Date data sharing statement initially provided
21/09/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimising Transition to Residential Aged Care
Scientific title
Implementing a Preventative Care Program to optimise mental health during transition into residential aged care
Secondary ID [1] 309608 0
MRF2016035
Universal Trial Number (UTN)
Trial acronym
AtRAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 329926 0
anxiety 329927 0
Condition category
Condition code
Mental Health 326828 326828 0 0
Depression
Mental Health 326829 326829 0 0
Anxiety
Mental Health 326830 326830 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this research is to obtain feasibility and acceptability outcomes for a new care pathway designed to better support the transition of new residents into residential aged care facilities (RACFs). The intervention has three arms: PEARL- program to support residents, aSTART- program to support families/carers, and Staff Training to support RACF staff.
1. PEARL- program to support residents.
The PEARL program is an evidence-based manualised program (Davison et al, 2020) based on self-determination theory and shown to assist aged care residents to adjust to their new residence and circumstances. In PEARL, residents will take part in five 1-hour talk-therapy sessions over 11 weeks. These sessions are delivered to newly arrived residents at the RACF by supervised psychology and occupational therapy students, who will undergo an additional 8 hours of online and face-to-face training in general counseling skills and the PEARL program. PEARL training is delivered by a member of the research team who is a clinical psychologist with experience both working with the aged population and in delivering the PEARL program. The first three PEARL sessions occur in consecutive weeks with session 4 occurring in Week 6 and the final session (5) occurring in Week 11.

In the PEARL program, residents work with therapists on tasks built developed based on self-determination theory and designed to improve adjustment to their new environment. The first three sessions cover content designed to improve autonomy, relatedness, and competence, while the final two sessions review previous learning and connect insights obtained in the first sessions with approaches available within the facility. The 11-week program also involves two staff-focused sessions in which the PEARL therapist connects with relevant staff to drive connection between the new resident and the facility and two "booster" sessions designed as collaborations between the resident, the PEARL leader, and facility staff. In all, PEARL is designed to give residents a chance to discuss their own preferences for life within the residential care facility and provide a space to talk about their emotional and social adjustment to their new environment.

PEARL is a manualised program with specific tasks to be completed at each session. Progress on the intervention is tracked by session checklists to be completed by the PEARL therapist and logged with the residential facility and research team.

PEARL reference: Davison, T.E., McCabe, M.P., Busija, L. et al. A cluster randomised trial of the program to enhance adjustment to residential living (PEARL): a novel psychological intervention to reduce depression in newly admitted aged care residents. BMC Geriatr 20, 98 (2020). https://doi.org/10.1186/s12877-020-1492-5

2. aSTART- program to support families/carers
The aSTART program is an adapted version of the evidence-based, manualised START program (Livingston, et al 2014) that is shown to support family carers of those living with dementia. The adapted aSTART focuses on supporting family carers of individuals who have made the transition to residential aged care. These adjustments have been made in collaboration with the research team who designed the original program to ensure the key focus and approach remain the same.
aSTART consists of up to 8 sessions focusing on psychoeducation of grief, depression, stress, and dementia, alongside practical strategies that family carer's can implement to better their own experiences of stress, as well as improving communication and interaction with their relative. The specific sessions to be completed within the aSTART program are determined collaboratively between the clinician and the participant in the first introductory session. aSTART will be offered via Telehealth or face-to-face the University of Newcastle’s Psychology Clinic or at RACFs. aSTART will be delivered by psychologists who will undergo an additional 8 hours of online and face-to-face training in the aSTART program. aSTART involves 5-8 talk therapy sessions (depending on client needs), each of which is designed to support family carers through changes in their role as their family member moves into RACF living. Training in the program is provided by clinical psychologists with experience in delivering the aSTART program and working with the specific population (i.e. relatives of older adults who are experiencing cognitive decline or have moved into residential aged care).
aSTART is manualised and flexible, allowing family carers to work with the therapist to tailor the program to their specific needs. For example, participants can decide to focus on behaviour management if this is a primary concern and/or if their relative has a dementia diagnosis, option dementia modules can be included. Each session has a programmed set of tasks and checklists are used to monitor progress.
aSTART will be offered to family carers of new residential care residents regardless of whether or not their relative has decided (or has the capacity) to participate in PEARL. Dyads are not required or assessed for this trial. Family carer's are offered participation in aSTART during their relative's orientation to the facility and may begin immediately after this date, but this is not essential. Researchers will re-offer the program twice in the first 6 weeks of their family members move into the facility.

START reference: Livingston, G., Barber, J., Rapaport, P., Knap, M., Griffin, M., Romeo, R., et al. (2014) START (STrAtegies for RelaTives) study: a pragmatic randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of a manual-based coping strategy programme in promoting the mental health of carers of people with dementia. Health Technol Assess, 18(61), https://doi.org/10.3310/hta18610times,

3. Staff training- supports for RACF staff
RACF staff will be supported with additional training in mental health, dignity of choice, and in understanding the PEARL program being delivered within their facility. This training is delivered by a Psychologist with both clinical and Ph.D. training and vast experience in the aged care field. The training is in face-to-face format on-site at their place of work and is 3 hours in duration. The training involves a combination of instructor-led learning of theory, interactive activities, group discussion, and case-study analysis. Participants are provided with a copy of workshop content as well as practical guides they may use to implement in their daily practice at the facility. Session participation is monitored by attendance check-lists and survey responses before and after the session.
Intervention code [1] 326031 0
Behaviour
Intervention code [2] 326032 0
Prevention
Comparator / control treatment
Pre-intervention, residents at the Residential Aged Care Facility (RACF) will receive usual primary health care and access to psychological services as required. This involves access to nurse and general practitioner services, and referral to (and services provided by) mental health teams as necessary.

The trial design is largely pre-post with no active control group. However, the health outcomes of the residents involved in the intervention will be compared to the outcomes of the previous 30 residents who were admitted to that facility. This information is obtained directly from resident medical files maintained by the RACF. An audit of the medical files for the previous 30 admissions will be conducted and health records obtained for mandatory collected data.
Control group
Historical

Outcomes
Primary outcome [1] 335148 0
Feasibility-Residents: Research consent rates for residents will be calculated by dividing the number of those eligible by the number who consent to take part in the research. The research will track all newly arriving residents from the commencement date of the project and identify which residents meet the eligibility criteria. From an audit of data, we will then identify the proportion of residents who were eligible and participated in PEARL and those who were eligible but chose not to participate.
Timepoint [1] 335148 0
This metric will be analysed at the conclusion of this arm of the study, specifically 1-month post-intervention completion by the final participant.
Primary outcome [2] 335149 0
Feasibility-Carers: Research consent rates for carers will be calculated by dividing the number of those eligible by the number who consent to take part in the research. The research will track all family carers who are offered the program from the commencement date of the project as meeting the eligibility criteria. From an audit of this data, we will then identify the proportion of carers who were offered the program and participated in aSTART and those who were eligible but chose not to participate.
Timepoint [2] 335149 0
This metric will be analysed at the conclusion of this arm of the study, specifically 1-month post-intervention completion by the final participant.
Primary outcome [3] 335240 0
Feasibility-Staff: Research consent rates for staff will be calculated by dividing the number of staff offered the program by the number who consent to take part in the research. The research will obtain counts of the number of staff offered in the training program. From an audit of this data, we will then identify the proportion of staff who were offered the training and participated in the training and those who were eligible but chose not to participate.
Timepoint [3] 335240 0
This metric will be analysed at the conclusion of this arm of the study, specifically 1-month post-intervention completion by the final participant.
Secondary outcome [1] 424195 0
Implementation of intervention- residents (PRIMARY outcome). The proportion of resident participants who participate in any PEARL session, and the proportion who complete all PEARL sessions. These process measures will be collected via log sheets and client records.
Timepoint [1] 424195 0
This metric will be analysed at the conclusion of this arm of the study, specifically 1-month post-intervention completion by the final participant.
Secondary outcome [2] 424196 0
Implementation of intervention- carers (PRIMARY outcome). The proportion of carer participants who participate in any START session and the proportion who participate in all START sessions. These process measures will be collected via log sheets and client records.
Timepoint [2] 424196 0
This metric will be analysed at the conclusion of this arm of the study, specifically 1-month post-intervention completion by the final participant.
Secondary outcome [3] 424197 0
Implementation of intervention- staff (PRIMARY outcome). the proportion of staff participants who complete the Dignity of Choice training. These process measures will be collected via log sheets and client records.
Timepoint [3] 424197 0
This metric will be analysed at the conclusion of this arm of the study, specifically 1-month post-intervention completion by the final participant.
Secondary outcome [4] 424198 0
Acceptability-Residents (PRIMARY outcome). Acceptability of the new care pathway will be assessed via qualitative interviews with 15 residents. These interviews will be semi-structured interviews conducted face-to-face at the residential aged care facility with a member of the research team trained in qualitative interview techniques.
Timepoint [4] 424198 0
Interviews will be conducted within 4 weeks after the completion of the PEARL intervention, and analysed thereafter.
Secondary outcome [5] 424199 0
Acceptability-Carers (PRIMARY outcome). Acceptability of the new care pathway will be assessed via qualitative interviews with 15 carers. These interviews will be semi-structured interviews conducted face-to-face at the residential aged care facility with a member of the research team trained in qualitative interview techniques.
Timepoint [5] 424199 0
Interviews will be conducted within 4 weeks after the completion of the aSTART intervention, and analysed thereafter.
Secondary outcome [6] 424200 0
Acceptability-Staff (PRIMARY outcome). Acceptability of the new care pathway will be assessed via qualitative interviews with 15 staff. These interviews will be semi-structured interviews conducted face-to-face at the residential aged care facility with a member of the research team trained in qualitative interview techniques.
Timepoint [6] 424200 0
Interviews will be conducted within 4 weeks after the completion of the PEARL intervention, and analysed thereafter.
Secondary outcome [7] 424201 0
For residents:
Depressive symptoms, as assessed by the Geriatric Depression Scale (GDS).
Timepoint [7] 424201 0
Immediately Pre-Intervention (before the first PEARL session)
Post-Intervention, within 1-week of the final session of PEARL is completed by each participant
Secondary outcome [8] 424202 0
For residents:
Quality of Life, as assessed by the Quality of Life in Alzheimer’s Disease (QoL-AD) scale
Timepoint [8] 424202 0
Immediately Pre-Intervention (before the first PEARL session)
Post-Intervention, within 1-week of the final session of PEARL is completed by each participant
Secondary outcome [9] 424203 0
For residents:
Social Isolation, as assessed by the Lubben Social Network Scale-6
Timepoint [9] 424203 0
Immediately Pre-Intervention (before the first PEARL session)
Post-Intervention, within 1-week of the final session of PEARL is completed by each participant
Secondary outcome [10] 424204 0
Residents:
Coping strategies, as assessed by The Brief COPE scale
Timepoint [10] 424204 0
Immediately Pre-Intervention (before the first PEARL session)
Post-Intervention, within 1-week of the final session of PEARL is completed by each participant
Secondary outcome [11] 424205 0
For residents:
Perceived life stress, as assessed by The Perceived Stress Scale (PSS-10)
Timepoint [11] 424205 0
Immediately Pre-Intervention (before the first PEARL session)
Post-Intervention, within 1-week of the final session of PEARL is completed by each participant
Secondary outcome [12] 424206 0
For residents:
Views regarding the move to residential aged care, as assessed by The View of Relocation Scale (VRS)
Timepoint [12] 424206 0
Immediately Pre-Intervention (before the first PEARL session)
Post-Intervention, within 1-week of the final session of PEARL is completed by each participant
Secondary outcome [13] 424207 0
For residents:
Satisfaction of basic needs, as assessed by The Basic Needs Satisfaction and Frustration Scale (BNSFS)
Timepoint [13] 424207 0
Immediately Pre-Intervention (before the first PEARL session)
Post-Intervention, within 1-week of the final session of PEARL is completed by each participant
Secondary outcome [14] 424208 0
For carers:
Anxiety and Depressive symptomology, as assessed by Hospital Anxiety and Depression Scale (HADS)
Timepoint [14] 424208 0
Immediately Pre-Intervention (before the first aSTART session)
Post-Intervention, within 1-week of the final session of aSTART is completed by each participant
Secondary outcome [15] 424209 0
For carers:
Quality of life, as assessed by WHOQoL-BREF
Timepoint [15] 424209 0
Immediately Pre-Intervention (before the first aSTART session)
Post-Intervention, within 1-week of the final session of aSTART is completed by each participant
Secondary outcome [16] 424210 0
For Carers:
Carer burden, as assessed by the Zarit Burden Interview
Timepoint [16] 424210 0
Immediately Pre-Intervention (before the first aSTART session)
Post-Intervention, within 1-week of the final session of aSTART is completed by each participant
Secondary outcome [17] 424211 0
For carers:
Coping skills, as assessed by the Brief COPE
Timepoint [17] 424211 0
Immediately Pre-Intervention (before the first aSTART session)
Post-Intervention, within 1-week of the final session of aSTART is completed by each participant
Secondary outcome [18] 424212 0
For carers:
Perceived stress, as assessed by The Perceived Stress Scale(PSS-10)
Timepoint [18] 424212 0
Immediately Pre-Intervention (before the first aSTART session)
Post-Intervention, within 1-week of the final session of aSTART is completed by each participant
Secondary outcome [19] 424213 0
For Staff:
Knowledge and confidence in Dignity of Choice, as assessed by a specific questionnaire designed by research partner Hunter Primary Care.
Timepoint [19] 424213 0
Immediately Pre-Training
Immediately Post-Training
3 Months Post-Training
Secondary outcome [20] 424214 0
For staff:
Depression knowledge and confidence in identifying decline in mental health, as assessed by the Mental Health Knowledge Schedule.
Timepoint [20] 424214 0
Immediately Pre-Training
Immediately Post-Training
3 Months Post-Training
Secondary outcome [21] 424215 0
For staff:
Job satisfaction in aged care settings, as assessed by Measure of Job Satisfaction (Chou, Boldy., & Lee, 2002)
Timepoint [21] 424215 0
Immediately Pre-Training
Immediately Post-Training
3 Months Post-Training
Secondary outcome [22] 424274 0
For residents:

Referrals to other allied health providers (a component of historical control comparison)

Identified from an audit of RACF records conducted by RACF staff and provided in de-identified format by RACF staff to the research team. Obtained for participants in the intervention condition as well as the 30 residents in the historical control group
Timepoint [22] 424274 0
For intervention participants: Post-Intervention, obtained for the 12-week duration of the PEARL program (inclusive of the week prior to the intervention during which information and consent processes take place.

For historical control participants: Obtained post the period of 12 weeks since their admission to the RACF.
Secondary outcome [23] 424275 0
For residents:

Number of hospitalisations (a component of historical control comparison)

Identified from an audit of RACF records conducted by RACF staff and provided in de-identified format by RACF staff to the research team. Obtained for participants in the intervention condition as well as the 30 residents in the historical control group
Timepoint [23] 424275 0
For intervention participants: Post-Intervention, obtained for the 12-week duration of the PEARL program (inclusive of the week prior to the intervention during which information and consent processes take place.

For historical control participants: Obtained post the period of 12 weeks since their admission to the RACF.
Secondary outcome [24] 424277 0
For residents:

Number of falls (a component of historical control comparison)

Identified from an audit of RACF records conducted by RACF staff and provided in de-identified format by RACF staff to the research team. Obtained for participants in the intervention condition as well as the 30 residents in the historical control group
Timepoint [24] 424277 0
For intervention participants: Post-Intervention, obtained for the 12-week duration of the PEARL program (inclusive of the week prior to the intervention during which information and consent processes take place.

For historical control participants: Obtained post the period of 12 weeks since their admission to the RACF.
Secondary outcome [25] 424278 0
For residents:
Psychotropic medication de/prescription (a component of historical control comparison)

Identified from an audit of RACF records conducted by RACF staff and provided in de-identified format by RACF staff to the research team. Obtained for participants in the intervention condition as well as the 30 residents in the historical control group
Timepoint [25] 424278 0
For intervention participants: Post-Intervention, obtained for the 12-week duration of the PEARL program (inclusive of the week prior to the intervention during which information and consent processes take place.

For historical control participants: Obtained post the period of 12 weeks since their admission to the RACF.

Eligibility
Key inclusion criteria
Residents: Newly admitted residents with and without depression/symptoms(and/or other mental illness) will be eligible to take part (recruitment target 30). They will need adequate English language to participate.

Families: Adult family members/carers of residents entering RACF will be eligible to participate (recruitment target 30). English language to participate

Staff: Twenty (or more) frontline staff (e.g., personal care workers, nurses, lifestyle officers, and allied health) at the Aged Care facility will be eligible and invited to take part in the study. English language to participate

Students on placement: Approximately fifteen students (psychology or occupational therapy) on placement who are involved in the delivery of the PEARL or aSTART programs as part of their course placements will be invited to take part in the study. English language to participate
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Residents: Residents with severe cognitive impairment (defined by Mini-Mental State Examination score of less than 1131)and those entering into palliative care will be ineligible to take part.

Families: No exclusion criteria

Staff: No exclusion criteria

Students: No exclusion criteria

Study design
Purpose of the study
Prevention
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The design is largely pre-post with a historical control group included for comparison of primary health outcomes. An audit of medical files maintained by the RACF will be conducted for the previous 30 admissions into the facility. This information will be provided in de-identified format by the facility to the research team and will capture information related to referrals to allied health providers, hospitalisations, falls, and psychotropic medication de/prescription. This data will serve as a historical control for the outcomes of the 30 residents involved in the intervention condition.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will assess the number and proportion of new residents and family members offered PEARL and aSTART respectively, the proportion who accept and complete these interventions, and the proportion of residential aged care facility staff who complete training. Interviews will be audio-recorded with participant consent and transcribed verbatim, with identifying data removed and analysed using an Inductive thematic analysis process. The inductive analysis involves: (i) identifying units of meaning using a process of reading the transcripts line-by-line; (ii) grouping units into categories whereby each category was labelled to assist with retrieval between the data; and (iii) examining relationships between codes in the context of the research question in order to form themes. To ensure accuracy, consensus coding will be undertaken by two researchers. Ideas, concepts, words or phrases that appear in the transcripts will be grouped into broader categories. From the category’s themes are developed, which capture or define the key messages that emerge from the data. Analysis will be undertaken by Dr White who will analyse all transcripts. Analysis and interpretation will be shared and agreed upon among the research team. In the case of discrepancies that cannot be resolved, a third researcher will be called upon to provide their interpretation. Basic quantitative data (pre-post measures) will be taken for staff completing training and residents and family completing programs. Paired analyses will be undertaken. The study will not be powered for effectiveness. Economic analysis will be undertaken by the health economics team at HMRI. The analysis, employing a societal perspective, will involve identifying, measuring and valuing the resource use, including opportunity costs, associated with the implementation strategies compared to usual care.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/05/2023
Date of last participant enrolment
Anticipated
1/12/2023
Actual
Date of last data collection
Anticipated
1/02/2024
Actual
Sample size
Target
100
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 40699 0
2304 - Sandgate
Recruitment postcode(s) [2] 40700 0
2308 - Newcastle University

Funding & Sponsors
Funding source category [1] 313788 0
University
Name [1] 313788 0
University of Newcastle
Country [1] 313788 0
Australia
Funding source category [2] 314196 0
Government body
Name [2] 314196 0
Australian Government Department of Health and Aged Care, Medical Research Future Fund (MRFF)
Country [2] 314196 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Dr, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 315621 0
Charities/Societies/Foundations
Name [1] 315621 0
Hunter Primary Care
Address [1] 315621 0
7 Warabrook Boulevard, Warabrook NSW 2304PO Box 572, Newcastle NSW 2300
Country [1] 315621 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312956 0
University of Newcastle Human Ethics Committee
Ethics committee address [1] 312956 0
Ethics committee country [1] 312956 0
Australia
Date submitted for ethics approval [1] 312956 0
30/11/2022
Approval date [1] 312956 0
10/01/2023
Ethics approval number [1] 312956 0
H-2022-0370

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

Contacts
Principal investigator
Name 126474 0
A/Prof Michelle Kelly
Address 126474 0
University of NewcastleRoom W-132Behavioural Sciences Building,University Drive, Callaghan, NSW 2308 Australia
Country 126474 0
Australia
Phone 126474 0
+61 2 49216838
Fax 126474 0
Email 126474 0
[email protected]
Contact person for public queries
Name 126475 0
Michelle Kelly
Address 126475 0
University of NewcastleRoom W-132Behavioural Sciences Building,University Drive, Callaghan, NSW 2308 Australia
Country 126475 0
Australia
Phone 126475 0
+61 2 49216838
Fax 126475 0
Email 126475 0
[email protected]
Contact person for scientific queries
Name 126476 0
Michelle Kelly
Address 126476 0
University of NewcastleRoom W-132Behavioural Sciences Building,University Drive, Callaghan, NSW 2308 Australia
Country 126476 0
Australia
Phone 126476 0
+61 2 49216838
Fax 126476 0
Email 126476 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19581Study protocol  [email protected] Access to study protocol is by contacting CI A/Pro... [More Details]



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