Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001177549
Ethics application status
Approved
Date submitted
13/09/2024
Date registered
25/09/2024
Date last updated
25/09/2024
Date data sharing statement initially provided
25/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Early allied health assessment for frail older adults.
Scientific title
Can an early allied health service improve time to discharge, patient and system outcomes for frail older adults? A before and after study.
Secondary ID [1] 312451 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 334284 0
Condition category
Condition code
Public Health 330941 330941 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The first 120 participants will be consecutively recruited to the control group where they will receive standard allied health care. The following 120 patients will receive the intervention, an early allied health assessment. Case matching between groups will be used based on age, gender, diagnosis and Clinical Frailty Scale (CFS).
The intervention group will receive early allied health input (completed by either a senior occupational therapist or physiotherapist) within one hour of presenting to the emergency department (ED). An early assessment will include obtaining verbal handover from the ambulance officers (if able), initial interview with the patient and/or caregiver, review of their current function and cognitive review. The early allied health assessment will take approximately 20-30 minutes to complete and include self-reported social history, pre-presentation physical function using a modified version of the Functional Independence Measure/Functional Assessment Method (FIM/FAM), falls history in the last 12 months and home environment setup, as well as a cognitive review (using the 4 ‘A’s Test [4AT]) and a Clinical Frailty Scale (CFS) score. A review of patients current function will be dependent on their reason for presentation, any contraindications for mobilising (i.e., concern there is a fracture, unable to mobilise since presentation) and their state of discomfort (i.e., complaints of pain or shortness of breath). Any concerns regarding assessing a patients function will be discussed with the nursing staff and triage/Rapid Assessment Team (RAT) doctor.
Initial interview and current function will be documented in the patient’s medical record. Individualised interventions such as falls risk minimisation strategies, nutrition and hydration assistance, prevention of medication adverse events (e.g. missed doses, lack of analgesia), promoting mobilisation and toileting, optimisation of patient positioning and pressure injury prevention, communication assistance (hearing device provision, speech to text device and app, information leaflets) and education may be recommended to support understanding and expectations of ED processes, maintenance of function and minimise adverse events during their ED stay. Patients that do not require further input from the ED allied health team will be discharged from the service with any equipment or outpatient referrals (such as home visiting, Rehabilitation in the Home [RITH] or outpatient geriatric clinics) completed by the early intervention therapist. Those patients requiring further allied health input, such as further assessment of function or cognition, will be referred to the ED allied health team within the department for ongoing assessment and management. Referrals may also be made to the ED social work team.
Verbal feedback will be provided to the allocated doctor for consideration during their assessment, including patients frailty score and risks, frailty interventions addressed (i.e., falls, cognition/delirium risk, continence), allied health recommendations (i.e., current function, social situations, discharge recommendations), advocating for specialist team input (i.e., geriatric team), transfer to specific ED areas for treatment and admission.
At the end of a patients presentation medical records will be reviewed regarding frailty interventions provided and referrals made to address frailty syndromes.
Intervention code [1] 328956 0
Early detection / Screening
Intervention code [2] 329549 0
Treatment: Other
Comparator / control treatment
The control group will be recruited prospectively first and will receive standard health care where referrals to allied health occur later in a patient’s journey (average of 5 hours). Referrals are often after medical review and based on the doctor’s clinical judgment, but may also come from nursing staff, social workers or geriatric team. Referrals are predominantly placed on the Emergency Department Information System, phoned through to the team or completed face to face, however some are initiated by the allied health team themselves based on their clinical reasoning.
Patients referred to the allied health team will receive an initial interview, functional assessment and cognitive review. Initial interview will be the same as the intervention group, including social history, CFS, FIM/FAM, falls history and cognitive screen. Patients may have an allied health assessment commenced prior to all investigations (i.e., blood tests or scans) being completed however, a functional review will only be completed with medical clearance either via an official report (i.e., Xray or CT scan final report) or verbal clearance from the treating ED doctor. If patients are deemed appropriate for discharge the allied health team will provide adaptive equipment and/or make outpatient referrals based on the outcome of their assessment (such as home visits, outpatient geriatric clinics [i.e. Frailty Rapid Access Clinic, falls, continents clinics], RITH).

Control group
Active

Outcomes
Primary outcome [1] 338719 0
Time from triage to departure between groups.
Timepoint [1] 338719 0
At time of ED discharge
Secondary outcome [1] 437112 0
Total number of patients discharged home between groups.
Timepoint [1] 437112 0
At the conclusion of study
Secondary outcome [2] 437127 0
Number of admitted bed days between groups
Timepoint [2] 437127 0
At time of hospital discharge
Secondary outcome [3] 437128 0
Number of referrals to specialist ED services, such as allied health and geriatric assessment team, between groups
Timepoint [3] 437128 0
At time of hospital discharge
Secondary outcome [4] 437130 0
Number of allied health contacts between groups
Timepoint [4] 437130 0
At time of hospital discharge
Secondary outcome [5] 437131 0
Disposition from ED between groups
Timepoint [5] 437131 0
At time of ED discharge
Secondary outcome [6] 437132 0
Number of frailty interventions provided between groups
Timepoint [6] 437132 0
At time of hospital discharge
Secondary outcome [7] 437133 0
Quality of life between groups
Timepoint [7] 437133 0
At ED presentation and at 6 months post ED discharge
Secondary outcome [8] 437134 0
Number of adverse events between groups
Timepoint [8] 437134 0
At time of hospital discharge
Secondary outcome [9] 439833 0
Function between groups
Timepoint [9] 439833 0
At ED presentation and at 6 months post ED discharge
Secondary outcome [10] 439834 0
Time from triage to allied health
Timepoint [10] 439834 0
At time of hospital discharge
Secondary outcome [11] 439835 0
Time from triage to medical
Timepoint [11] 439835 0
At time of hospital discharge
Secondary outcome [12] 439836 0
Time from triage to geriatric team assessment
Timepoint [12] 439836 0
At time of hospital discharge
Secondary outcome [13] 439837 0
Time from allied health discharge to ED departure
Timepoint [13] 439837 0
At time of hospital discharge
Secondary outcome [14] 439838 0
Time from geriatric team discharge to departure
Timepoint [14] 439838 0
At time of hospital discharge
Secondary outcome [15] 439839 0
Time from medical assessment to allied health assessment
Timepoint [15] 439839 0
At time of hospital discharge
Secondary outcome [16] 439840 0
Time from allied health to geriatric team assessment
Timepoint [16] 439840 0
At time of hospital discharge

Eligibility
Key inclusion criteria
Patients
• Aged 65 years and older
• Clinical Frailty Scale (CFS) of four to six
• Australasian Triage Score (ATS) of three to five
• Diagnosis of a fall, generalised or non-specific illness, musculoskeletal injury or back pain with disease states or organ impairment).
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients
• Patients from a residential aged care facility
• Unable to provide informed consent (i.e., psychosis, delirium, cognitive impairment)
• Presenting outside the ED allied health teams hours of service

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)
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
Before and after with case matching
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A statistician has been involved in the study design and data analysis plan.

The before and after study uses descriptive statistics for patient characteristics which will consist of proportions, percentages, ranges, means and standard deviations, and medians and interquartile ranges (where data is skewed). Differences between the intervention and control group for ED LOS will be analysed using an independent t test, if test assumptions are met. Correlation and regression analysis will be used to explore the relationship between early allied health intervention and ED LOS, as well as for frailty clinical care (such as frailty screen and interventions) and system outcomes (such as waiting times, hospital LOS and representations).

Differences between the intervention and control group for ED LOS will be analysed using an independent t test, if test assumptions are met. Correlation and regression analysis will be used to explore the relationship between early allied health intervention and ED LOS, as well as referrals to ED older adult services and frailty-associated diagnoses and interventions.

Primary outcome: Differences between the intervention and control group for ED LOS will be analysed using an independent t test, if test assumptions are met.

Secondary outcomes: Correlation and regression analysis will be used to explore the relationship between early allied health intervention and ED LOS, as well as referrals to ED older adult services and frailty-associated diagnoses and interventions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
241
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 26763 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 42812 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 316867 0
Government body
Name [1] 316867 0
Government of Western Australia Department of Health - Future Health Research and Innovation fund
Country [1] 316867 0
Australia
Funding source category [2] 316885 0
University
Name [2] 316885 0
Curtin University
Country [2] 316885 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Country
Australia
Secondary sponsor category [1] 319145 0
None
Name [1] 319145 0
Address [1] 319145 0
Country [1] 319145 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315626 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 315626 0
Ethics committee country [1] 315626 0
Australia
Date submitted for ethics approval [1] 315626 0
22/07/2024
Approval date [1] 315626 0
14/08/2024
Ethics approval number [1] 315626 0
RGS0000006897

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

Contacts
Principal investigator
Name 135306 0
Miss Melinda Williamson
Address 135306 0
Sir Charles Gairdner Hospital, Hospital Ave, Nedlands, WA, 6007
Country 135306 0
Australia
Phone 135306 0
+61 0401100494
Fax 135306 0
Email 135306 0
melinda.williamson@health.wa.gov.au
Contact person for public queries
Name 135307 0
Melinda Williamson
Address 135307 0
Sir Charles Gairdner Hospital, Hospital Ave, Nedlands, WA, 6007
Country 135307 0
Australia
Phone 135307 0
+61 0401100494
Fax 135307 0
Email 135307 0
melinda.williamson@health.wa.gov.au
Contact person for scientific queries
Name 135308 0
Melinda Williamson
Address 135308 0
Sir Charles Gairdner Hospital, Hospital Ave, Nedlands, WA, 6007
Country 135308 0
Australia
Phone 135308 0
+61 0401100494
Fax 135308 0
Email 135308 0
melinda.williamson@health.wa.gov.au

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?

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.