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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.
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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.
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Secondary ID [1]
312451
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Frailty
334284
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Condition category
Condition code
Public Health
330941
330941
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
328956
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Early detection / Screening
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Intervention code [2]
329549
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Treatment: Other
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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).
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Control group
Active
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Outcomes
Primary outcome [1]
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Time from triage to departure between groups.
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Assessment method [1]
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Information will be sourced from hospital systems, such as the Emergency Department Information System (EDIS) and i.Clinical Manager.
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Timepoint [1]
338719
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At time of ED discharge
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Secondary outcome [1]
437112
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Total number of patients discharged home between groups.
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Assessment method [1]
437112
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Information will be sourced from hospital systems, such as the Emergency Department Information System (EDIS) and i.Clinical Manager.
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Timepoint [1]
437112
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At the conclusion of study
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Secondary outcome [2]
437127
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Number of admitted bed days between groups
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Assessment method [2]
437127
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Information will be sourced from hospital systems, such as the Emergency Department Information System (EDIS) and i.Clinical Manager.
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Timepoint [2]
437127
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At time of hospital discharge
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Secondary outcome [3]
437128
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Number of referrals to specialist ED services, such as allied health and geriatric assessment team, between groups
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Assessment method [3]
437128
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Information will be sourced from hospital systems, such as the Emergency Department Information System (EDIS) and i.Clinical Manager.
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Timepoint [3]
437128
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At time of hospital discharge
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Secondary outcome [4]
437130
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Number of allied health contacts between groups
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Assessment method [4]
437130
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Information will be sourced from hospital systems, such as Allied Health Systems.
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Timepoint [4]
437130
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At time of hospital discharge
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Secondary outcome [5]
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Disposition from ED between groups
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Assessment method [5]
437131
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Information will be sourced from hospital systems, such as the Emergency Department Information System (EDIS) and i.Clinical Manager.
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Timepoint [5]
437131
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At time of ED discharge
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Secondary outcome [6]
437132
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Number of frailty interventions provided between groups
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Assessment method [6]
437132
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Information sourced from the patients medical record
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Timepoint [6]
437132
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At time of hospital discharge
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Secondary outcome [7]
437133
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Quality of life between groups
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Assessment method [7]
437133
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Quality of life will be assessed using the Short form 6D-version two
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Timepoint [7]
437133
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At ED presentation and at 6 months post ED discharge
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Secondary outcome [8]
437134
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Number of adverse events between groups
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Assessment method [8]
437134
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Information will be sourced from hospital systems, such as the Emergency Department Information System (EDIS) and i.Clinical Manager.
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Timepoint [8]
437134
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At time of hospital discharge
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Secondary outcome [9]
439833
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Function between groups
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Assessment method [9]
439833
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Abbreviated version of Functional independence Measure/Functional Assessment Method (FIM/FAM)
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Timepoint [9]
439833
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At ED presentation and at 6 months post ED discharge
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Secondary outcome [10]
439834
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Time from triage to allied health
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Assessment method [10]
439834
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Information will be sourced from hospital systems, such as the Emergency Department Information System (EDIS) and i.Clinical Manager.
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Timepoint [10]
439834
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At time of hospital discharge
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Secondary outcome [11]
439835
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Time from triage to medical
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Assessment method [11]
439835
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Information will be sourced from hospital systems, such as the Emergency Department Information System (EDIS) and i.Clinical Manager.
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Timepoint [11]
439835
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At time of hospital discharge
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Secondary outcome [12]
439836
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Time from triage to geriatric team assessment
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Assessment method [12]
439836
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Information will be sourced from hospital systems, such as the Emergency Department Information System (EDIS) and i.Clinical Manager.
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Timepoint [12]
439836
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At time of hospital discharge
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Secondary outcome [13]
439837
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Time from allied health discharge to ED departure
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Assessment method [13]
439837
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Information will be sourced from hospital systems, such as the Emergency Department Information System (EDIS) and i.Clinical Manager.
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Timepoint [13]
439837
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At time of hospital discharge
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Secondary outcome [14]
439838
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Time from geriatric team discharge to departure
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Assessment method [14]
439838
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Information will be sourced from hospital systems, such as the Emergency Department Information System (EDIS) and i.Clinical Manager.
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Timepoint [14]
439838
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At time of hospital discharge
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Secondary outcome [15]
439839
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Time from medical assessment to allied health assessment
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Assessment method [15]
439839
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Information will be sourced from hospital systems, such as the Emergency Department Information System (EDIS) and i.Clinical Manager.
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Timepoint [15]
439839
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At time of hospital discharge
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Secondary outcome [16]
439840
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Time from allied health to geriatric team assessment
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Assessment method [16]
439840
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Information will be sourced from hospital systems, such as the Emergency Department Information System (EDIS) and i.Clinical Manager.
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Timepoint [16]
439840
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At time of hospital discharge
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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).
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Before and after with case matching
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Phase
Not Applicable
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Type of endpoint/s
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2024
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Actual
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Date of last participant enrolment
Anticipated
31/03/2025
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Actual
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Date of last data collection
Anticipated
1/10/2025
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Actual
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Sample size
Target
241
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
26763
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
42812
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6009 - Nedlands
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Funding & Sponsors
Funding source category [1]
316867
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Government body
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Name [1]
316867
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Government of Western Australia Department of Health - Future Health Research and Innovation fund
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Address [1]
316867
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Country [1]
316867
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Australia
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Funding source category [2]
316885
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University
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Name [2]
316885
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Curtin University
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Address [2]
316885
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Country [2]
316885
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Australia
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Primary sponsor type
Hospital
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Name
Sir Charles Gairdner Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
319145
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None
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Name [1]
319145
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Address [1]
319145
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Country [1]
319145
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315626
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Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
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Ethics committee address [1]
315626
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https://www.scgh.health.wa.gov.au/Research/Department-of-Research/My-Project/HREC
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Ethics committee country [1]
315626
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Australia
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Date submitted for ethics approval [1]
315626
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22/07/2024
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Approval date [1]
315626
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14/08/2024
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Ethics approval number [1]
315626
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RGS0000006897
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Summary
Brief summary
Those living with frailty are at greater risk of adverse events when attending the Emergency Department (ED). Gold standard practice for frail older patients is a multidimensional multidisciplinary comprehensive geriatric assessment (CGA). However, routine completion is difficult in the ED setting due to increasing demand, overcrowding and patient flow issues, but has shown positive outcomes when used selectively with patients at high risk of adverse events. Allied health professionals often contribute to the multidisciplinary process providing comprehensive care to ED patients, However, referrals are traditionally received after medical intervention which can cause delays in decision making and discharge. The project aims to implement an early allied health assessment for frail older adults presenting to the ED. They will provide individualised interventions to priority patients, minimising the risk of adverse events and gathering valuable information regarding social complexities and function earlier to assist discharge decision making, facilitating patient flow through the ED and improve patient outcomes and experience.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Miss Melinda Williamson
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Address
135306
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Sir Charles Gairdner Hospital, Hospital Ave, Nedlands, WA, 6007
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Country
135306
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Australia
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Phone
135306
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+61 0401100494
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Fax
135306
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Email
135306
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[email protected]
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Contact person for public queries
Name
135307
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Melinda Williamson
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Address
135307
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Sir Charles Gairdner Hospital, Hospital Ave, Nedlands, WA, 6007
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Country
135307
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Australia
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Phone
135307
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+61 0401100494
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Fax
135307
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Email
135307
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[email protected]
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Contact person for scientific queries
Name
135308
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Melinda Williamson
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Address
135308
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Sir Charles Gairdner Hospital, Hospital Ave, Nedlands, WA, 6007
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Country
135308
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Australia
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Phone
135308
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+61 0401100494
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Fax
135308
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Email
135308
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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