Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001008516
Ethics application status
Approved
Date submitted
30/07/2024
Date registered
20/08/2024
Date last updated
20/08/2024
Date data sharing statement initially provided
20/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising older People's Transition from acute care Into residential aged care through Multidisciplinary Assessment and Liaison (OPTIMAL)
Scientific title
The implementation and clinical effectiveness of a risk adjusted post-discharge intervention to prevent readmission in older individuals transitioning from acute care to residential aged care for the first time.
Secondary ID [1] 312204 0
MRFF 2022, Application ID 2018250 (Work Package 3)
Universal Trial Number (UTN)
U1111-1308-8240
Trial acronym
OPTIMAL (Optimising older People's Transition from acute care Into residential aged care through Multidisciplinary Assessment and Liaison)
Linked study record
MRFF 2022 Models of care to improve the efficiency and effectiveness of acute care grant,

Health condition
Health condition(s) or problem(s) studied:
Preventable readmissions among individuals aged 65 years and older discharged from hospital to a residential aged care facility for the first time 333879 0
Condition category
Condition code
Physical Medicine / Rehabilitation 330555 330555 0 0
Other physical medicine / rehabilitation
Public Health 330556 330556 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves risk stratification and implementation of a customised bundle of interventions for hospitalised older patients who are being discharged to residential aged care for the first time.

The study aims to evaluate the implementation and clinical effectiveness of introducing a risk adjusted post-discharge bundle of interventions to support older adults transitioning from hospital to residential aged care for the first time. Previous research from the United States shows that this can significantly reduce preventable readmissions. This approach has previously not been tested in the Australian setting where it is known that 22.6% of individuals who transition to residential aged care for the first time re-present to an emergency department, and 18% will have an unplanned hospitalisation within 90 days.

We will conduct a stepped wedge randomised controlled trial with embedded process evaluation across multiple hospital sites in three local health networks (LHN) in South Australia: South Adeliade Local Health Network (SALHN), Central Adelaide Local Health Network (CALHN) and Northern Adelaide Local Health Network (NALHN). Randomisation will be at the level of the LHN.

The study population is people aged 65 years and older, discharged from hospital to a residential aged care facility for the first time.

We will select up to twelve wards across the selected hospitals in the three LHN. Each LHN will be randomised to either the control or intervention phase, with one LHN per randomisation, and all wards within an LHN will commence the intervention together.

Over 14 months, we will enroll 1545 participants across the three LHNs. We will implement the intervention in four steps, with 74 participants per LHN in the first step (establishment phase), and 147 participants per LHN per step in subsequent steps. Data of all eligible patients from the selected hospital wards will be collected until the target sample size is reached. The project budget will fund a nurse facilitator in each LHN, who will be a SALHN/CALHN/NALHN employed clinician having access to hospital electronic records and working and communicating with the ward staff. This position is a Level 3 Registered Nurse, and their role is that of an internal facilitator to ensure that evidence-based practice occurs. The nurse facilitator will have experience working with older people and be familiar with residential care facilities and understand dementia.

In the establishment phase: all selected wards will deliver usual care. The data dashboard will be developed and introduced to staff in the LHNs. The discharge note will be implemented and introduced to staff. A nurse facilitator will be appointed to each LHN at least one month prior to the intervention start. The nurse facilitator will work with the clinical teams in each LHN to agree on the evidence bundle of interventions to be implemented for each level of readmission risk. We will carry out pre-implementation context mapping interviews with key decision makers from each LHN and surveys of clinical managers and members of clinical teams.

In the intervention phase eligible patients will be stratified based on risk of readmission and the agreed bundle of interventions will be delivered by the LHN team, based on the patient's assessed risk. We will be using a tool developed for this population to stratify patients based on their risk of readmission (1) when they are ready for discharge from the hospital. The tool has been incorporated into a data dashboard which utilises the EMR data (including gender, age, past medical history, prescribed medications (such as warfarin, anticholinergics and proton pump inhibitors), and number of previous hospitalisations and unplanned ED presentations within defined periods), to categorise eligible patients into risk levels. Risk of readmission will be higher in patients who are male, age more than 90 years, having a history of delirium, Dementia, incontinence, on specific medications, hospitalised in the past 30 days or one year, or had unplanned ED presentations in the preceding 30 days.

Based on their risk level, individuals will receive a customized post-discharge bundle of interventions. Each LHN will be responsible to select the bundle of evidence-based interventions that will be implemented in their sites (there is no defined number of interventions to be implemented, but the selected interventions should be stratified according to the assessed risk). Interventions may include (1) a post-discharge phone call within 48-72 hours, (2) medication reconciliation by a pharmacist within one week, (3) same-day discharge summaries, (4) access to a geriatric hotline, and (5) a visit from an advanced geriatric practice nurse within seven days. High risk patients may transition service navigator for a month post discharge, while low-risk patients may only receive a timely discharge summary and a phone call. As this is a stepped wedge cluster randomised controlled trial, the length of the intervention phase will be 12 months for LHN 1, 8 months for LHN 2 and 4 months for LHN 3. The LHNs will serve as their own controls.

Outcomes will be monitored using the data dashboard. The primary outcome is readmissions within the first 30- and 90-days post-discharge and the secondary outcomes are the length of stay during readmission and the proportion of eligible patients who receive the risk stratified bundle of interventions. Process evaluation will include assessment of the acceptability, adoption, feasibility and fidelity of implementation. We will carry out implementation context-mapping interviews with key decision makers from each LHN and surveys of clinical managers and members of clinical teams. Adherence to the intervention will be assessed through the activity log and field notes maintained by the nurse facilitator.

In the post intervention phase, we will monitor outcomes and complete data analysis. We will carry out post implementation context-mapping interviews with key decision makers from each LHN and surveys of clinical managers and members of clinical teams. We will disseminate the results to identified stakeholders and promote translation of findings.

The materials that will be used include:
- Interview guides for the pre-intervention, intervention and post intervention context mapping interviews. The interview guides are designed to obtain insights on the context in which implementation takes place, with regards to the innovation (what the current practice is and how the intervention is perceived), recipients (who would be involved, their role in implementation, the available capacity and support, additional resources required, and possible challenges), the local context, organisational context and external health system (facilitators and barriers to implementation)..
- Survey questionnaire (via Qualtrics) for the pre-intervention, intervention and post intervention context mapping surveys, which is expected to take 15 minutes to complete.
- Participant information and consent forms for the interviews and surveys.
- Poster to be displayed in participating wards to provide information to patients and families about the study. The poster explains that we are working on improving the quality of transfers to residential care and are tracking the outcomes of patients on this ward to monitor whether they return to hospital. It includes a contact number for the nurse facilitator whom patients and families can contact should they have any queries about the study.
- Activity log and field notes to be maintained by nurse facilitator in each LHN, which will contribute to process evaluation

Procedures, activities and processes include:
- Steering committee meetings. The Steering Committee provides high level oversight and guidance to the project. The Steering Committee meets monthly for a duration of one hour, and comprises the core research team, the implementing leads and team from each LHN.
- Project planning workshops with stakeholders, overall and at the LHN level
- Development of data dashboard to identify & risk stratify patients and follow up for outcomes
- Establishment of LHN implementation committees and regular meetings of committees
- Develop LHN specific SOP (procedures for intervention will be decided by each LHN)
- Education/training sessions for clinicians on using the data dashboard, the OPTIMAL intervention, and the LHN specific SOP. These sessions will be conducted during the establishment phase, with a duration of one hour each. They will be organised by the nurse facilitator for each LHN, conducted by LHN leads and implementing team, with the support of members of the core research team.

The bundle of interventions will be delivered in person or over the phone, as decided by each LHN team. The intensity of the intervention for each level of risk and the person who will deliver the intervention will also be decided by the LHN team. The intervention will take place in the selected hospitals, prior to discharge and in the residential aged care facility.

1. Inacio MC, Jorissen RN, Wesselingh S, Sluggett JK, Whitehead C, Maddison J, et al. Predictors of hospitalisations and emergency department presentations shortly after entering a residential aged care facility in Australia: a retrospective cohort study. BMJ Open. 2021;11(11):e057247.
Intervention code [1] 328731 0
Prevention
Comparator / control treatment
Participants in the control phase will receive the usual care that is given to patients being discharged to residential aged care, which includes a discharge summary at entry to the residential aged care facility.
As this is a stepped wedge cluster randomised controlled trial, the selected wards will serve as their own controls.
Control group
Active

Outcomes
Primary outcome [1] 338406 0
Readmissions within 30 days of index discharge
Timepoint [1] 338406 0
30 days after index discharge
Primary outcome [2] 338407 0
Readmissions within 90 days of index discharge.
Timepoint [2] 338407 0
90 days after index discharge
Secondary outcome [1] 435809 0
Length of stay out of hospital (30 days)
Timepoint [1] 435809 0
30 days after index discharge
Secondary outcome [2] 435810 0
Length of stay out of hospital (90 days)
Timepoint [2] 435810 0
90 days after index discharge
Secondary outcome [3] 437071 0
Proportion of eligible patients who receive the risk stratified bundle of interventions
Timepoint [3] 437071 0
90 days after index discharge

Eligibility
Key inclusion criteria
Patients aged 65 years and older who will be discharged from hospital to a residential aged care facility for the first time.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a planned surgical intervention which will require readmission within the 90 days following hospital discharge

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer. Each of the three LHN will be randomised to either the control or intervention phase, with one LHN per randomisation.
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The study design is a stepped wedge cluster randomised controlled trial. Randomisation will be at the level of the LHN. Each LHN will be randomised to either the control or intervention phase, with one LHN per randomisation, and all selected wards within an LHN will commence the intervention together. The selected wards will serve as their own controls. There will be four steps: the first step lasting 2 months, and four months per step in subsequent steps (a total of 14 months).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Over a period of 14 months, we will enroll 1545 participants from up to twelve wards across the three LHN. Each LHN will be randomized to either the control or intervention phase, with one LHN per randomization. We will implement the intervention in four steps, with 74 participants per LHN in the first step, and 147 participants per LHN per step in subsequent steps. Previous research has shown that the incidence of unplanned ED presentations and hospitalisations within 90 days of entering residential aged care for the first time is 22.6% and 18% respectively. Our sample size was calculated to ensure that the study has sufficient statistical power for analysis of the outcome measure (the proportion of older patients discharged to residential aged care who were readmitted within 90 days of the date of discharge). We anticipate that we will be able to detect a significant reduction in 90-day readmissions from 20% to 10% in the intervention phase, with 80% power and a significance level of 5%. This accounts for 10% attrition due to deaths or withdrawals.

We will collect 12 months of baseline data for all LHN prior to the first LHN commencing the establishment phase.

While every effort will be made to ensure the data is as complete as possible, we will employ appropriate statistical techniques for managing any missing data and will run analysis to check for any between group differences that may confound the results. We will report the results using the CONSORT 2010 guidelines for randomised trials with the extension for stepped-wedge trials.

Analysis of effectiveness outcomes:
In addition to initial descriptive analysis, one-way analysis of variance (ANOVA) will be used to test group differences. Subgroup analysis will also be done comparing participants of different demographics and for each LHN. Readmission and length of hospital stay at readmission after the index admission between intervention and control conditions will be compared using generalised linear mixed models accounting for clustering by wards and adjusting for credible confounders to further control baseline imbalance. Results will be presented as means with 95% confidence intervals.

Readmissions within 30 days after discharge will be analysed using a binomial regression model with readmission within 30 days of the index discharge (Yes/No) as the binary response variable. The main result of this analysis is the effect of the intervention on the proportion of patients discharged to residential aged care for the first time who present to Emergency Department and/or are readmitted within 30 days from the date of index discharge, so the main variable will be whether the discharging ward is in control or intervention phase. Patients who die within 30 days of the index discharge will be excluded from the analysis. The model will adjust for potential confounders including patient age, sex, and clinical history. We will add a linear time covariate to account for any potential time trend over the period of data collection.

Readmissions within 90 days after discharge will be analysed using a binomial regression model as described above with readmission within 90 days of the index discharge (Yes/No) as the binary response variable.

Length of stay out of hospital will be analysed for all patients using a generalised linear regression model. The main result of this analysis is the effect of the intervention on the length of stay out of hospital. The main variable will be whether the discharging ward is in control or intervention phase. The model will adjust for potential confounders including patient demographics and time to readmission from index discharge. We will add a linear time covariate to account for any potential time trend over the period of data collection.

Analysis of implementation outcomes (Process Evaluation):
The process evaluation will include evaluation of the acceptability, adoption, feasibility and fidelity of implementing the intervention. Thematic analysis of interview notes and transcripts from the pre-implementation, implementation and evaluation interviews will be carried out, supplemented by survey responses. Nurse facilitators in each LHN will be required to maintain and activity log and field notes, which will also be analysed. Interviews will be recorded (with participants’ permission) via either a digital recording device for face-to-face interviews or via Microsoft Teams for Teams interviews. Recordings will be transcribed, either using the transcription function in Teams or by a transcription company. Recordings will be uploaded to and transcripts downloaded from the transcription company online via our password protected account. Transcripts will be de-identified by removing the participants’ names. Analysis will be iterative to identify emerging themes and then refined. The transcripts will be analysed by an experienced qualitative researcher using NVivo software to code qualitative data into categories then narrowed down into overarching themes, using the i-PARIHS as a conceptual framework. A selection of qualitative interviews will be analysed by a second member of the research team to check for agreement in coding. Any discrepancies will be discussed, and the coding frame clarified. Survey questionnaire responses will be recorded using the Qualtrics platform, exported from Qualtrics to an Excel spreadsheet and uploaded to the Mi-PARIHS Facilitation Implementation tool for analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
31/01/2026
Actual
Sample size
Target
1545
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 26634 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 26635 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 26636 0
Noarlunga Health Service - Noarlunga Centre
Recruitment hospital [4] 26637 0
Repat Neuro-Behavioural Unit - Daw Park
Recruitment hospital [5] 26638 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [6] 26639 0
Modbury Hospital - Modbury
Recruitment postcode(s) [1] 42674 0
5000 - Adelaide
Recruitment postcode(s) [2] 42675 0
5042 - Bedford Park
Recruitment postcode(s) [3] 42676 0
5168 - Noarlunga Centre
Recruitment postcode(s) [4] 42677 0
5041 - Daw Park
Recruitment postcode(s) [5] 42678 0
5112 - Elizabeth Vale
Recruitment postcode(s) [6] 42679 0
5092 - Modbury

Funding & Sponsors
Funding source category [1] 316580 0
Government body
Name [1] 316580 0
Australian Government, Department of Health and Aged Care, Medical Research Future Fund
Country [1] 316580 0
Australia
Primary sponsor type
University
Name
College of Medicine and Public Health, Flinders University
Address
Country
Australia
Secondary sponsor category [1] 318760 0
University
Name [1] 318760 0
Caring Futures Institute, Flinders University
Address [1] 318760 0
Country [1] 318760 0
Australia
Other collaborator category [1] 283065 0
Charities/Societies/Foundations
Name [1] 283065 0
South Australian Health and Medical Research Institute
Address [1] 283065 0
Country [1] 283065 0
Australia
Other collaborator category [2] 283066 0
Government body
Name [2] 283066 0
Commission on Excellence and Innovation in Health
Address [2] 283066 0
Country [2] 283066 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315366 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 315366 0
Ethics committee country [1] 315366 0
Australia
Date submitted for ethics approval [1] 315366 0
08/09/2023
Approval date [1] 315366 0
13/09/2023
Ethics approval number [1] 315366 0
2023/HRE00111

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

Contacts
Principal investigator
Name 134478 0
Prof Maria Crotty
Address 134478 0
College of Medicine and Public Health, Flinders University, GPO Box 2100, Adelaide 5001, South Australia. Office: Rehabilitation and Palliative Care Building, Flinders Medical Centre, Bedford Park, 5041 SA
Country 134478 0
Australia
Phone 134478 0
+61 8 7421 9791
Fax 134478 0
Email 134478 0
[email protected]
Contact person for public queries
Name 134479 0
Prof Gillian Harvey
Address 134479 0
College of Nursing and Health Sciences, Flinders University, GPO Box 2100, Adelaide 5001, South Australia. Office: Rehabilitation and Palliative Care Building, Flinders Medical Centre, Bedford Park, 5041 SA
Country 134479 0
Australia
Phone 134479 0
+61 8 7421 9422
Fax 134479 0
Email 134479 0
[email protected]
Contact person for scientific queries
Name 134480 0
Prof Gillian Harvey
Address 134480 0
College of Nursing and Health Sciences, Flinders University, GPO Box 2100, Adelaide 5001, South Australia. Office: Rehabilitation and Palliative Care Building, Flinders Medical Centre, Bedford Park, 5041 SA
Country 134480 0
Australia
Phone 134480 0
+61 8 7421 9422
Fax 134480 0
Email 134480 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified individual participant data (with a unique participant number) collected during the trial will be shared.
When will data be available (start and end dates)?
Data will be available immediately following publication of main results, no end date determined.
Available to whom?
Only researchers who provide a methodologically sound proposal, to be decided on a case-by-case basis at the discretion of the Primary Sponsor.
Available for what types of analyses?
For IPD meta-analysis
How or where can data be obtained?
Access subject to approvals by Principal Investigator - can be contacted via email to [email protected].


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.