Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000263493
Ethics application status
Approved
Date submitted
27/03/2025
Date registered
9/04/2025
Date last updated
9/04/2025
Date data sharing statement initially provided
9/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Allied Health Assistant Care for Patients with Acute Hip Fracture and Cognitive Impairment
Scientific title
Allied Health Assistant Care for Patients with Acute Hip Fracture and Cognitive Impairment: a feasibility randomised controlled trial
Secondary ID [1] 314043 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip fracture 336787 0
Cognitive impairment 336924 0
Condition category
Condition code
Physical Medicine / Rehabilitation 333276 333276 0 0
Physiotherapy
Injuries and Accidents 333277 333277 0 0
Fractures
Public Health 333278 333278 0 0
Health service research
Neurological 333393 333393 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name of intervention: Allied health assistant provision of routine post-operative hip fracture rehabilitation

Who will deliver the intervention and what is their training: The intervention will be delivered by a senior allied health assistant (grade 3). The allied health assistant will have a certificate IV allied health assistant qualification. A senior (grade 3) acute orthopaedic physiotherapist will supervise the senior allied health assistant as per health network clinical supervision guidelines. This supervision will include monthly meetings to discuss professional and clinical skill development in the management of people with cognitive impairment recovering from hip fracture. It will also involve direct supervision/observation of the senior allied health assistant's management of people with cognitive impairment recovering from hip fracture.

Mode of delivery: Individual, face-to-face

Dose: Daily therapy provided on weekdays (i.e. daily therapy 5x per week) until discharge from acute hospital. Initial physiotherapy assessment may occur on a Saturday if hip fracture surgery performed on a Friday. The duration of each session will vary dependent on patient needs but is expected to be approximately 20-30 minutes.

Location/Timing: Therapy will be provided to patients with cognitive impairment recovering from hip fracture surgery on the orthopaedic ward at Frankston Hospital. Therapy will be provided by the allied health assistant following an initial post-operative physiotherapy assessment of the patient. The allied health assistant will be delegated provision of routine post-operative hip fracture rehabilitation if the patient with cognitive impairment is transferred to sitting out of bed during the physiotherapy assessment and appropriate for mobilisation (walking). This process will involve the physiotherapist completing an initial assessment and providing a thorough handover to the allied health assistant.

Procedures and personalisation: Routine acute rehabilitation of patients with hip fracture should include daily mobilisation (i.e. walking) as per Australian and New Zealand Hip Fracture Registry Guidelines and may also include:
1) progression of gait aid
2) skills-based functional standing/seated exercises (e.g. squats, sit-to-stand, calf raises)
3) education (e.g. falls risk strategies)

All therapy will be prescribed by the physiotherapist who conducts the initial assessment and tailored to the individual needs of the patient and the therapy will be implemented by the allied health assistant. The level of intensity of exercise is not specified because the intervention is skill-based involving task-specific practice (e.g., mobility rehabilitation). As per standard protocol, following treatment of the patient with cognitive impairment and hip fracture the allied health assistant will inform the physiotherapist, who completed the initial assessment, of the details of the session and the patient's progress in their ability to mobilise. The physiotherapist will use this feedback to determine the discharge plan and re-assess the patient as required.

Fidelity The fidelity of the intervention will be determined by measuring the time and occasions of service each patient spends with i) the physiotherapist and ii) the allied health assistant.
Intervention code [1] 330624 0
Rehabilitation
Comparator / control treatment
Name of comparator treatment: Physiotherapy provision of routine post-operative hip fracture rehabilitation

Who will deliver the intervention and what is their training: The intervention will be delivered by accredited and practising physiotherapists

Mode of delivery: Individual, face-to-face

Dose: Daily (5x per week) therapy until discharge from acute hospital. Initial physiotherapy assessment may occur on a Saturday if hip fracture surgery performed on a Friday. The duration of each session will vary dependent on patient needs but is expected to be approximately 20-30 minutes.

Location/Timing: All therapy will be provided to patients with cognitive impairment recovering from hip fracture surgery on the orthopaedic ward at Frankston Hospital. Therapy will be provided by the physiotherapist following their initial post-operative assessment of the patient.
Procedures and Personalisation: Routine acute rehabilitation of patients with hip fracture should include daily mobilisation (i.e. walking) as per Australian and New Zealand Hip Fracture Registry Guidelines and may also include:
1) progression of gait aid
2) skills-based functional standing/seated exercises (e.g. squats, sit-to-stand, calf raises)
3) education (e.g. falls risk strategies)

All therapy will be tailored to the individual needs of the patient. The level of intensity of exercise is not specified because the intervention is skill-based involving task-specific practice (e.g., mobility rehabilitation). Allied health assistants may assist the therapist to mobilise a patient who requires the assistance of two people but will not be delegated the role of providing daily mobilisation or rehabilitation.

Fidelity: The fidelity of the comparator treatment will be determined by measuring the time and occasions of service each patient spends with i) the physiotherapist and ii) the allied health assistant.
Control group
Active

Outcomes
Primary outcome [1] 340850 0
Feasibility: Demand Domain (Primary Outcome) - recruitment rate
Timepoint [1] 340850 0
Upon conclusion of the study.
Primary outcome [2] 340851 0
Feasibility: Implementation Domain (Primary Outcome) - physiotherapist contact time
Timepoint [2] 340851 0
Time of discharge from acute hospital
Primary outcome [3] 340852 0
Feasibility: Implementation Domain (Primary Outcome) - allied health assistant contact time
Timepoint [3] 340852 0
Time of discharge from acute hospital
Secondary outcome [1] 445248 0
Feasibility: Implementation Domain (Primary Outcome) - number of physiotherapist occasions of service provided
Timepoint [1] 445248 0
Time of discharge from acute hospital
Secondary outcome [2] 445249 0
Feasibility: Implementation Domain (Primary Outcome) - number of allied health assistant occasions of service provided
Timepoint [2] 445249 0
Time of discharge from acute hospital
Secondary outcome [3] 445250 0
Feasibility: Practicality Domain (Primary Outcome) - cost of acute physiotherapy service
Timepoint [3] 445250 0
Time of discharge from acute hospital
Secondary outcome [4] 445251 0
Feasibility: Practicality Domain (Primary Outcome) - cost of acute patient hospital care
Timepoint [4] 445251 0
Time of discharge from acute hospital
Secondary outcome [5] 445252 0
Feasibility: Practicality Domain (Primary Outcome) - adverse events
Timepoint [5] 445252 0
Time of discharge from acute hospital.
Secondary outcome [6] 445253 0
Feasibility: Acceptability Domain (Primary Outcome) - patient satisfaction with physiotherapy and allied health assistant care
Timepoint [6] 445253 0
Time of discharge from acute hospital.
Secondary outcome [7] 445254 0
Feasibility: Acceptability Domain (Primary Outcome) - adherence to mobilisation with physiotherapist or allied health assistant
Timepoint [7] 445254 0
Time of discharge from acute hospital.
Secondary outcome [8] 445255 0
Compliance with Australian and New Zealand Hip Fracture Registry (ANZHFR) Hip Fracture Clinical Care Guidelines (Secondary Outcome).
Timepoint [8] 445255 0
Time of discharge from acute hospital.
Secondary outcome [9] 445256 0
Reasons for Not Mobilising (Secondary Outcome)
Timepoint [9] 445256 0
Time of discharge from acute hospital.
Secondary outcome [10] 445257 0
Discharge Destination from Acute Hospital (Secondary Outcome)
Timepoint [10] 445257 0
Time of discharge from acute hospital.
Secondary outcome [11] 445258 0
Falls (Secondary Outcome)
Timepoint [11] 445258 0
Time of discharge from acute hospital.
Secondary outcome [12] 445259 0
Patient Function - Level of Assistance (Secondary Outcome)
Timepoint [12] 445259 0
Time of commencement of rehabilitation from either the allied health assistant or physiotherapist (i.e. baseline) and time of discharge from acute hospital.
Secondary outcome [13] 445260 0
Discharge Destination from Sub-Acute Hospital (Secondary Outcome)
Timepoint [13] 445260 0
Time of discharge from sub-acute hospital.
Secondary outcome [14] 445261 0
Length of Acute Hospital Stay (Secondary Outcome)
Timepoint [14] 445261 0
Time of discharge from acute hospital.
Secondary outcome [15] 445262 0
Length of Sub-Acute Hospital Stay (Secondary Outcome)
Timepoint [15] 445262 0
Time of discharge from sub-acute hospital.
Secondary outcome [16] 445263 0
30-day hospital re-admission (Secondary Outcome)
Timepoint [16] 445263 0
30-days following discharge from health service
Secondary outcome [17] 445264 0
Cost of Sub-Acute Patient Care (Secondary Outcome)
Timepoint [17] 445264 0
Time of discharge from sub-acute hospital.

Eligibility
Key inclusion criteria
Eligible participants will be patients with cognitive impairment who have undergone surgery for management of hip fracture at the participating acute hospital site. Participants must meet the following eligibility criteria:
• Inpatient at Frankston Hospital
• Admission diagnosis of hip fracture (S72.0–S72.2 according to the International Classification of Diseases 10th revision (ICD-10)
• Walked pre-hip fracture with or without the use of a walking aid
• Impaired cognition (Short Portable Mental Status Questionnaire Score <6, with 5 or more errors)
• Willingness and ability, as determined by initial physiotherapy assessment, to participate in post-operative physiotherapy
• Aged 18 years or older
• Able to communicate in conversational English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• No or minimal cognitive impairment (Short Portable Mental Status Questionnaire Score greater than or equal to 6, with 4 or fewer errors)
• Patients unable to participate in physiotherapy rehabilitation (e.g. patients with a post-operative lower extremity touch or non-weight bearing status)
• Patients who were non-ambulant pre-hip fracture
• Patients not suitable for mobilisation or physiotherapy

If the patient is not appropriate for mobilisation, based on initial physiotherapy assessment, they will not be eligible for participation in the study. However, participants are eligible for inclusion in the study if their medical stability improves on any day during their admission. Mobilisation will be contraindicated if the patient experiences any of the following complications:
• Severe post-operative pain that restricts weight bearing
• Nausea or vomiting with or without antimetic
• Vitally unstable: postural blood pressure drop, febrile, bradycardia <40bpm or abnormal heart rhythm
• Disorientated, heavily sedated or difficult to rouse.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be determined by contact with an independent researcher after the member of the research team has determined eligibility for the study, participants and/or their medical treatment decision maker have consented to take part, and baseline assessment has been completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to the experimental (allied health assistant care) or control (physiotherapy care) group using simple randomisation. Participants will be randomly assigned remotely using simple randomisation design with a computer random number generator prepared by an independent researcher not involved in the screening process, or collection of data.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics will be used to describe the characteristics of the sample by group (means [SD], median [IQR}, percentages and frequencies) as well as patient satisfaction, time physiotherapist/allied health assistant spends with patient, cost of physiotherapy service/patient care and adverse events.

Adherence to daily mobilisation guidelines will be collected in the form of time-to-event data, and mobilisation rate ratios will be calculated using Cox proportional hazards regression to directly compare mobilisation rates in the intervention and control (comparison) conditions.

As patients can have multiple mobilisations and are not eligible for subsequent mobilisation until initial mobilisation has occurred, recurrent event data will be analysed via the Williams and Peterson Gap time survival model, with robust standard errors to account for correlation within patients. In the survival analyses, discharge will be considered a censoring event. This equates to an assumption that data regarding mobilisation on days following discharge are missing at random (given timing of discharge). The appropriateness of this assumption will be checked in sensitivity analyses. No interim analyses will be conducted.

Length of stay will be analysed using survival analysis (time-to-discharge) with death as a competing risk. Physical function will be analysed using t-tests. Dichotomous outcomes include discharge destination (home vs. residential care), 30-day re-admission (30-day re-admission vs. no re-admission) and faller (fall vs. no falls) will be analysed with logistic regression. Cost of admission will be analysed using t-tests.

Should there be a significant difference in falls between the intervention group and the usual care group, the cost per fall avoided will be presented as an incremental cost effectiveness ratio (ICER; difference in cost divided by the difference in effect). The ICER will be calculated using the bootstrap methods and presented on a cost effectiveness plane to determine fall-related cost-effectiveness of the intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
2/06/2026
Actual
Date of last data collection
Anticipated
26/02/2027
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27666 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 43841 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 318549 0
Hospital
Name [1] 318549 0
Peninsula Health
Country [1] 318549 0
Australia
Funding source category [2] 318550 0
University
Name [2] 318550 0
La Trobe University
Country [2] 318550 0
Australia
Primary sponsor type
Hospital
Name
Peninsula Health
Address
Country
Australia
Secondary sponsor category [1] 320947 0
None
Name [1] 320947 0
Address [1] 320947 0
Country [1] 320947 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317149 0
Peninsula Health Human Research Ethics Committee
Ethics committee address [1] 317149 0
Ethics committee country [1] 317149 0
Australia
Date submitted for ethics approval [1] 317149 0
23/12/2024
Approval date [1] 317149 0
12/03/2025
Ethics approval number [1] 317149 0
Ethics committee name [2] 317150 0
La Trobe University Human Ethics Committee
Ethics committee address [2] 317150 0
Ethics committee country [2] 317150 0
Australia
Date submitted for ethics approval [2] 317150 0
13/03/2025
Approval date [2] 317150 0
24/03/2025
Ethics approval number [2] 317150 0

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

Contacts
Principal investigator
Name 140166 0
Dr David Snowdon
Address 140166 0
La Trobe University, Kingsbury Drive, Bundoora, VIC 3086
Country 140166 0
Australia
Phone 140166 0
+61 3 9479 2132
Fax 140166 0
Email 140166 0
[email protected]
Contact person for public queries
Name 140167 0
David Snowdon
Address 140167 0
La Trobe University, Kingsbury Drive, Bundoora, VIC 3086
Country 140167 0
Australia
Phone 140167 0
+61 3 9479 2132
Fax 140167 0
Email 140167 0
[email protected]
Contact person for scientific queries
Name 140168 0
David Snowdon
Address 140168 0
La Trobe University, Kingsbury Drive, Bundoora, VIC 3086
Country 140168 0
Australia
Phone 140168 0
+61 3 9479 2132
Fax 140168 0
Email 140168 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 5 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.