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DEFINITIONS
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
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Scientific title
Allied Health Assistant Care for Patients with Acute Hip Fracture and Cognitive Impairment: a feasibility randomised controlled trial
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Secondary ID [1]
314043
0
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:
Hip fracture
336787
0
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Cognitive impairment
336924
0
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Condition category
Condition code
Neurological
333393
333393
0
0
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Other neurological disorders
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Injuries and Accidents
333277
333277
0
0
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Fractures
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Public Health
333278
333278
0
0
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Health service research
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Physical Medicine / Rehabilitation
333276
333276
0
0
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Physiotherapy
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
330624
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Rehabilitation
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Feasibility: Demand Domain (Primary Outcome) - recruitment rate
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Assessment method [1]
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Demand domain will be evaluated by measuring the recruitment rate (comparing the number of people recruited to the number of potentially eligible participants). These data will be collected prospectively by monitoring the number of patients who 1) meet the eligibility criteria and 2) participate in the trial and documented in trial recruitment records. At the conclusion of the trial, the recruitment records will be audited to determine recruitment rates.
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Timepoint [1]
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Upon conclusion of the study.
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Primary outcome [2]
340852
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Feasibility: Implementation Domain (Primary Outcome) - allied health assistant contact time
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Assessment method [2]
340852
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Implementation domain will be evaluated by measuring the amount of time that allied health assistant spends providing therapy to the patient. This information will be collected using the hospital network Electronic Medical Record system. This information is routinely collected by the system and is recorded in patient medical records. It will be recorded as either 1) direct contact activities (e.g. providing therapy) or 2) indirect contact activities (e.g. typing notes). Direct contact activities and indirect contact activities will be measured as a composite outcome.
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Timepoint [2]
340852
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Time of discharge from acute hospital
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Primary outcome [3]
340851
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Feasibility: Implementation Domain (Primary Outcome) - physiotherapist contact time
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Assessment method [3]
340851
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Implementation domain will be evaluated by measuring the amount of time that physiotherapist spends providing therapy to the patient. This information will be collected using the hospital network Electronic Medical Record system. This information is routinely collected by the system and is recorded in patient medical records. It will be recorded as either 1) direct contact activities (e.g. providing therapy) or 2) indirect contact activities (e.g. typing notes). Direct contact activities and indirect contact activities will be measured as a composite outcome
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Timepoint [3]
340851
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Time of discharge from acute hospital
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Secondary outcome [1]
445250
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Feasibility: Practicality Domain (Primary Outcome) - cost of acute physiotherapy service
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Assessment method [1]
445250
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Practicality domain will be evaluated by measuring the cost of acute physiotherapy service. Cost of physiotherapy service will be calculated using the time spent treating and managing patients with hip fracture and pay rates for physiotherapists and allied health assistants. The time physiotherapists and allied health assistants spend treating patients will be collected from the hospital network electronic medical record system. Pay rates will be obtained from the Victorian Government award rates for physiotherapists and allied health assistants.
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Timepoint [1]
445250
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Time of discharge from acute hospital
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Secondary outcome [2]
445258
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Falls (Secondary Outcome)
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Assessment method [2]
445258
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The incidence of inpatient falls will be recorded as a composite outcome, where a fall is defined as 'unintentionally coming to rest on the ground, floor, or other lower level'. These data will be obtained from patient medical records and the hospital network's incident reporting system.
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Timepoint [2]
445258
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Time of discharge from acute hospital.
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Secondary outcome [3]
445256
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Reasons for Not Mobilising (Secondary Outcome)
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Assessment method [3]
445256
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Documented reasons for patients not mobilising will be audited from patient medical records. Days on which mobilisation is medically contraindicated will be recorded, ensuring rates of mobilisation reflect only days on which patients were deemed medically suitable for mobilsiation. Patients will be contraindicated on any day one or more of the following complications are experienced: • 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
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Timepoint [3]
445256
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Time of discharge from acute hospital.
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Secondary outcome [4]
445255
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Compliance with Australian and New Zealand Hip Fracture Registry (ANZHFR) Hip Fracture Clinical Care Guidelines (Secondary Outcome).
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Assessment method [4]
445255
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Compliance with the ANZHFR hip fracture clinical practice guideline requires patients with hip fracture to be mobilised at least once a day. Therefore. the number of days that the patient mobilises during their acute hospital stay will be audited from patient medical records.
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Timepoint [4]
445255
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Time of discharge from acute hospital.
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Secondary outcome [5]
445251
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Feasibility: Practicality Domain (Primary Outcome) - cost of acute patient hospital care
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Assessment method [5]
445251
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Practicality domain will be evaluated by measuring the cost of acute patient hospital care. Cost of patient care will be calculated using length of stay and hospital admission costs for the 2024-2025 and 2025-2026 financial years. Length of stay will be audited from patient medical records. Cost per day of hospital admission will be obtained from the Australian Institute of Health and Welfare.
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Timepoint [5]
445251
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Time of discharge from acute hospital
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Secondary outcome [6]
445262
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Length of Sub-Acute Hospital Stay (Secondary Outcome)
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Assessment method [6]
445262
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Patient length of stay will be measured as the number of days from patient admission to sub-acute hospital to discharge from sub-acute hospital Length of stay will be audited from patient medical records.
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Timepoint [6]
445262
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Time of discharge from sub-acute hospital.
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Secondary outcome [7]
445261
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Length of Acute Hospital Stay (Secondary Outcome)
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Assessment method [7]
445261
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Patient length of stay will be measured as the number of days from patient admission to acute hospital to discharge from acute hospital. Length of stay will be audited from patient medical records.
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Timepoint [7]
445261
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Time of discharge from acute hospital.
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Secondary outcome [8]
445252
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Feasibility: Practicality Domain (Primary Outcome) - adverse events
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Assessment method [8]
445252
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Practicality domain will be evaluated by measuring adverse events. Adverse events will include any incident of patient harm that is recorded in the Hospital Network incident reporting system and/or medical record. Possible examples of patient harm events include falls and unconscious collapse/vasovagal. Patient harm events will be further classified as 1) 'not related to the study', 'probably not related to the study', 'unlikely but possibly related' or 'probably related to the study' by an independent. medical academic, and 2) ‘serious’ or ‘non-serious’.
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Timepoint [8]
445252
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Time of discharge from acute hospital.
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Secondary outcome [9]
445249
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Feasibility: Implementation Domain (Primary Outcome) - number of allied health assistant occasions of service provided
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Assessment method [9]
445249
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Implementation domain will be evaluated by measuring the number of allied health assistant occasions of service provided to the patient. An occasion of service involves only direct patient activities (i.e. providing therapy). This information will be collected using the hospital network Electronic Medical Record system. This information is routinely collected by the system and is recorded in patient medical records.
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Timepoint [9]
445249
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Time of discharge from acute hospital
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Secondary outcome [10]
445260
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Discharge Destination from Sub-Acute Hospital (Secondary Outcome)
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Assessment method [10]
445260
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Discharge destination will be selected from the following list of possible destinations: (i) home: (ii) relative/friend's home; (iii) residential care. Discharge destination will be audited from patient medical records.
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Timepoint [10]
445260
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Time of discharge from sub-acute hospital.
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Secondary outcome [11]
445259
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Patient Function - Level of Assistance (Secondary Outcome)
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Assessment method [11]
445259
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Patients' functional activity at discharge will be measured using the Modified Iowa Level of Assistance Scale (mlLOA). The mlLOA consists of six items and measures the assistance required to achieve functional tasks, including moving from lying to sitting on the edge of the bed; moving from sitting to standing; walking; and negotiating one step. It also measures walking distance and the use of an assistive device.
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Timepoint [11]
445259
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Time of commencement of rehabilitation from either the allied health assistant or physiotherapist (i.e. baseline) and time of discharge from acute hospital.
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Secondary outcome [12]
445264
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Cost of Sub-Acute Patient Care (Secondary Outcome)
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Assessment method [12]
445264
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Cost of patient care will be calculated using length of stay and hospital admission costs for the 2024-2025 and 2025-2026 financial years.
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Timepoint [12]
445264
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Time of discharge from sub-acute hospital.
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Secondary outcome [13]
445257
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Discharge Destination from Acute Hospital (Secondary Outcome)
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Assessment method [13]
445257
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Discharge destination will be selected from the following list of possible destinations: (i) home: (ii) relative/friend's home: (iii) sub-acute rehab/geriatric evaluation management unit: (iv) inpatient transition care program, (v) residential care. Discharge destination will be audited from patient medical records.
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Timepoint [13]
445257
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Time of discharge from acute hospital.
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Secondary outcome [14]
445248
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Feasibility: Implementation Domain (Primary Outcome) - number of physiotherapist occasions of service provided
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Assessment method [14]
445248
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Implementation domain will be evaluated by measuring the number of physiotherapist occasions of service provided to the patient. An occasion of service involves only direct patient activities (i.e. providing therapy). This information will be collected using the hospital network Electronic Medical Record system. This information is routinely collected by the system and is recorded in patient medical records.
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Timepoint [14]
445248
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Time of discharge from acute hospital
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Secondary outcome [15]
445253
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Feasibility: Acceptability Domain (Primary Outcome) - patient satisfaction with physiotherapy and allied health assistant care
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Assessment method [15]
445253
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Acceptability domain will be evaluated by measuring patient satisfaction with physiotherapy and allied health assistant care. Patient satisfaction with physiotherapy care will be measured using a modified version of a questionnaire for patients receiving inpatient orthopaedic physiotherapy care. The original version of the questionnaire has been validated for use in an inpatient orthopaedic population by Ampiah and colleagues (2019). The patient rates their agreement with each of 11 statements on a 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). For the purpose of this study, we will use a modified version with six of the items removed. The items related to financial cost of physiotherapy care, diagnosis, time from physiotherapy referral to assessment, equipment available to the physiotherapist/assistant and compliance with physiotherapy will be removed from the questionnaire.
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Timepoint [15]
445253
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Time of discharge from acute hospital.
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Secondary outcome [16]
445263
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30-day hospital re-admission (Secondary Outcome)
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Assessment method [16]
445263
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30-day hospital readmission includes any unplanned readmission within 30 days of discharge from the health service (i.e., readmission from private residence) and will be collected from patient medical records.
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Timepoint [16]
445263
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30-days following discharge from health service
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Secondary outcome [17]
445254
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Feasibility: Acceptability Domain (Primary Outcome) - adherence to mobilisation with physiotherapist or allied health assistant
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Assessment method [17]
445254
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Acceptability domain will be evaluated by measuring adherence to mobilisation with physiotherapist or allied health assistant: • Participants who mobilise (i.e., step transfer, walk) with the physiotherapist or allied health assistant will be considered to have adhered to mobilisation. • Adherence will be measured as the number of days that a participant mobilises with the physiotherapist or allied health assistant relative to the number of days that the participant is medically stable to mobilise during their acute hospital admission. • Participants who refuse mobilisation, and are medically stable to mobilise, will be considered to have not adhered. Adherence will be determined by auditing patient medical files.
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Timepoint [17]
445254
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Time of discharge from acute hospital.
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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
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Minimum age
18
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
• 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
2/06/2025
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Actual
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Date of last participant enrolment
Anticipated
2/06/2026
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Actual
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Date of last data collection
Anticipated
26/02/2027
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
27666
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Frankston Hospital - Frankston
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Recruitment postcode(s) [1]
43841
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3199 - Frankston
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Funding & Sponsors
Funding source category [1]
318549
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Hospital
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Name [1]
318549
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Peninsula Health
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Address [1]
318549
0
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Country [1]
318549
0
Australia
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Funding source category [2]
318550
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University
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Name [2]
318550
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La Trobe University
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Address [2]
318550
0
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Country [2]
318550
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Australia
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Primary sponsor type
Hospital
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Name
Peninsula Health
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
320947
0
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Address [1]
320947
0
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Country [1]
320947
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317150
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La Trobe University Human Ethics Committee
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Ethics committee address [1]
317150
0
https://www.latrobe.edu.au/researchers/research-office/ethics/human-ethics
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Ethics committee country [1]
317150
0
Australia
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Date submitted for ethics approval [1]
317150
0
13/03/2025
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Approval date [1]
317150
0
24/03/2025
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Ethics approval number [1]
317150
0
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Ethics committee name [2]
317149
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Peninsula Health Human Research Ethics Committee
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Ethics committee address [2]
317149
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https://www.peninsulahealth-research.org.au/ethics/human-research-ethics-committee/
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Ethics committee country [2]
317149
0
Australia
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Date submitted for ethics approval [2]
317149
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23/12/2024
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Approval date [2]
317149
0
12/03/2025
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Ethics approval number [2]
317149
0
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Summary
Brief summary
This randomised controlled trial will investigate the feasibility of an allied health assistant providing physiotherapy to people with cognitive impairment following hip fracture surgery. The allied health assistant will provide all therapy to people in hospital. All therapy will be prescribed by a physiotherapist and will include daily walking, standing and seated exercises. We hypothesise that it is feasible for allied health assistants to provide physiotherapy to people with cognitive impairment after hip fracture surgery.
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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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Dr David Snowdon
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Address
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La Trobe University, Kingsbury Drive, Bundoora, VIC 3086
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Country
140166
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Australia
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Phone
140166
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+61 3 9479 2132
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Fax
140166
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Email
140166
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[email protected]
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Contact person for public queries
Name
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David Snowdon
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Address
140167
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La Trobe University, Kingsbury Drive, Bundoora, VIC 3086
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Country
140167
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Australia
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Phone
140167
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+61 3 9479 2132
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Fax
140167
0
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Email
140167
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[email protected]
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Contact person for scientific queries
Name
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David Snowdon
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Address
140168
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La Trobe University, Kingsbury Drive, Bundoora, VIC 3086
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Country
140168
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Australia
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Phone
140168
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+61 3 9479 2132
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Fax
140168
0
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Email
140168
0
[email protected]
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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.
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