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Trial registered on ANZCTR


Registration number
ACTRN12620000877987
Ethics application status
Approved
Date submitted
11/06/2020
Date registered
3/09/2020
Date last updated
16/05/2024
Date data sharing statement initially provided
3/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Post-operative physiotherapy provided by Allied Health Assistants for Patients with Hip Fracture
Scientific title
Post-operative physiotherapy provided by Allied Health Assistants for Patients with Acute Hip Fracture: a feasibility randomised controlled trial
Secondary ID [1] 301423 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Fracture 317704 0
Condition category
Condition code
Physical Medicine / Rehabilitation 315782 315782 0 0
Physiotherapy
Injuries and Accidents 316093 316093 0 0
Fractures
Public Health 316094 316094 0 0
Health service research

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 recovering from hip fracture. It will also involve direct supervision/observation of the senior allied health assistant’s management of people 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.
Location/Timing: All therapy will be provided to patients 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 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) 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 implementd by the allied health assistant. As per standard protocol, following treatment of the patient with 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] 317735 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: One to 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 session will vary dependent on patient needs.
Location/Timing: All therapy will be provided to patients 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) 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 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] 323990 0
Feasibility: Demand Domain (Primary Outcome)
Demand domain will be evaluated by measuring the recruitment rate (comparing the number of people recruited to the number of potentially eligible participants). This data will be collected prospectively by monitoring the number of patients who 1) meet the eligibility criteria and 2) participate in the trial.
Timepoint [1] 323990 0
Time of discharge from acute hospital.
Primary outcome [2] 324289 0
Feasibility: Implementation Domain (Primary Outcome)
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.
Timepoint [2] 324289 0
Time of discharge from acute hospital
Primary outcome [3] 324290 0
Feasibility: Implementation Domain (Primary Outcome)
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.
Timepoint [3] 324290 0
Time of discharge from acute hospital
Secondary outcome [1] 383508 0
Feasibility: Implementation Domain (Primary Outcome)
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.
Timepoint [1] 383508 0
Time of discharge from acute hospital.
Secondary outcome [2] 383509 0
Feasibility: Implementation Domain (Primary Outcome)
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.
Timepoint [2] 383509 0
Time of discharge from acute hospital.
Secondary outcome [3] 383511 0
Feasibility: Practicality Domain (Primary Outcome)
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.
Timepoint [3] 383511 0
Time of discharge from acute hospital.
Secondary outcome [4] 383512 0
Feasibility: Practicality Domain (Primary Outcome)
Practicality domain will be evaluated by measuring the cost of acute patient care.
Cost of patient care will be calculated using length of stay and hospital admission costs for the 2020-21 financial year. Length of stay will be calculated using the hospital network electronic medical record system. Cost per day of hospital admission will be obtained from the Australian Institute of Health and Welfare.
Timepoint [4] 383512 0
Time of discharge from acute hospital.
Secondary outcome [5] 383513 0
Feasibility: Practicality Domain (Primary Outcome)
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 ‘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.
Timepoint [5] 383513 0
Time of discharge from acute hospital.
Secondary outcome [6] 384248 0
Feasibility: Acceptability Domain (Primary Outcome)
Acceptability domain will be evaluated by measuring patient satisfaction with physiotherapy care. Patient satisfaction with physiotherapy care will be measured using a modified version of a questionnaire for hospital inpatients 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 statement 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.
Timepoint [6] 384248 0
Time of discharge from acute hospital.
Secondary outcome [7] 384252 0
Feasibility: Demand, Implementation, Practicality and Acceptability Domain (Primary Outcome)
Demand, Implementation, Practicality and Acceptability domain will be evaluated by conducting in depth semi-structured interviews with physiotherapists and the allied health assistant who are involved in the implementation of this model of care. The semi-structured interviews will be conducted one-to-one, using an interview guide, and audio-recorded. The interviews will explore their experience with this model of care.

Following cessation of patient participant recruitment and outcome assessment.
Timepoint [7] 384252 0
Following cessation of patient participant recruitment and outcome assessment.
Secondary outcome [8] 384253 0
Compliance with Australian and New Zealand Hip Fracture Registry (ANZHFR) Hip Fracture Clinical Care Guidelines (Secondary Outcome).
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 the their acute hospital stay will be audited from patient medical records.

Time of discharge from acute hospital.
Timepoint [8] 384253 0
Time of discharge from acute hospital .
Secondary outcome [9] 384254 0
Reasons for Not Mobilising (Secondary Outcome).
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
Timepoint [9] 384254 0
Time of discharge from acute hospital.
Secondary outcome [10] 384255 0
Discharge Destination From Acute Hospital (Secondary Outcome).
Discharge destination will be selected from the following list of possible destinations: (i) home; (ii) relative/friend’s home; (iii) residential care; (iv) inpatient transition care program, (v) sub-acute rehab/geriatric evaluation management unit.

Discharge destination will be audited from patient medical records.
Timepoint [10] 384255 0
Time of discharge from acute hospital.
Secondary outcome [11] 384256 0
Falls (Secondary Outcome).
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’.

Falls will be further classified to reflect the degree of harm; falls that result in either the permanent or temporary loss of function will be classified as an injurious fall, while falls that result in no loss of function will be classified as a non-injurious fall. Fall rate will be expressed as falls per 1000 bed days and this data will be obtained from patient medical records and the hospital network's incident reporting system.
Timepoint [11] 384256 0
Time of discharge from acute hospital.
Secondary outcome [12] 384257 0
Patient Functional Activity - Level of Assistance (Secondary Outcome):
Patients’ functional activity at discharge will be measured by assessing the assistance they require to (I) walk, (ii) transfer from a bed to a chair and (iii) go up/down a step. This method of measuring functional performance has been used previously in the post-orthopaedic surgery population. Level of assistance required to transfer, walk and go up/down a step are classified as: 0 – non-ambulant/fully dependent, 1 – assist of two people to walk/transfer, 2 – assist of one person to walk/transfer, 3 – supervised walking/transfer, 4 – independent walking/transfer.

This information is routinely recorded by physiotherapy and/or nursing staff and will be obtained by auditing patients' medical records.
Timepoint [12] 384257 0
Time of discharge from acute hospital.
Secondary outcome [13] 384258 0
Patient Functional Activity - Walking Endurance (Secondary Outcome).
Patients’ functional activity at discharge will be measured by assessing their walking endurance. This method of measuring functional performance has been used previously in the post-orthopaedic surgery population. Level of endurance are classified as: 0 – non-ambulant/less than 5 m, 1 – walked 5 m, 2 – walked 15 m, 3 – walked 50 m, 4 – walked 100 m or greater.
Timepoint [13] 384258 0
Time of discharge from acute hospital.
Secondary outcome [14] 384259 0
Discharge Destination From Sub-Acute Hospital (Secondary Outcome).
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.
Timepoint [14] 384259 0
Time of discharge from sub-acute hospital.
Secondary outcome [15] 384260 0
Length of Acute Hospital Stay (Secondary Outcome).
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.
Timepoint [15] 384260 0
Time of discharge from acute hospital.
Secondary outcome [16] 384261 0
Length of Sub-Acute Hospital Stay (Secondary Outcome).
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.
Timepoint [16] 384261 0
Time of discharge from sub-acute hospital.
Secondary outcome [17] 385310 0
Total Length of Stay (Secondary Outcome)
Patient length of stay will be measured as the number of days from patient admission to acute hospital to discharge from sub-acute hospital

Length of stay will be audited from patient medical records.
Timepoint [17] 385310 0
Time of discharge from sub-acute hospital.
Secondary outcome [18] 385311 0
Discharge Destination From Sub-Acute Hospital (Secondary Outcome).
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.
Timepoint [18] 385311 0
Time of discharge from sub-acute hospital.
Secondary outcome [19] 385312 0
Cost of Sub-Acute Physiotherapy Service (Secondary Outcome)
Cost of physiotherapy service will be calculated using the time spent treating and managing patients with hip fracture and pay rates for allied health assistants and physiotherapists. 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.
Timepoint [19] 385312 0
Time of discharge from sub-acute hospital.
Secondary outcome [20] 385313 0
Cost of Sub-Acute Patient Care (Secondary Outcome).
Cost of patient care will be calculated using length of stay and hospital admission costs for the 2020-21 financial year. Length of stay will be calculated using the hospital network electronic medical record system. Cost per day of hospital admission will be obtained from the Australian Institute of Health and Welfare.

Timepoint [20] 385313 0
Time of discharge from sub-acute hospital.

Eligibility
Key inclusion criteria
Patient participants
Eligible participants will be patients who have undergone surgery for management of hip fracture at the participating acute hospital site. Participants must meet the following eligibility criteria:
• Inpatient at acute hospital participating site
• Admission diagnosis of hip fracture (S72.0–S72.2 according to the International Classification of Diseases 10th revision (ICD-10)
• Walked independently pre-hip fracture with or without the use of a walking aid
• Willingness and ability (i.e. medically stable), as determined by initial physiotherapy assessment, to participate in post-operative physiotherapy
• Aged 18 years or older
• Able to provide written, informed consent
• Able to communicate in conversational English

Staff participants:
Staff participants for this project include any allied health assistant, physiotherapist or manager involved in the implementation of the allied health assistant model of care. They will include the following staff who either i) work on the orthopaedic ward at the acute hospital participating site or ii) have managerial oversight of physiotherapists working on the orthopaedic ward.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient Participants:
Exclusion criteria are:
• 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 OR required assistance of another person to walk pre-hip fracture
• Patient not suitable for mobilisation or physiotherapy
• Impaired cognition (Short Portable Mental Status Questionnaire Score <8)

If the patient is not appropriate for mobilisation 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.

Staff Participants:
Staff who are not involved in the implementation of the allied health assistant model of care will not be eligible for inclusion.

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 email or phone contact with an independent researcher after the member of the research team has determined eligibility for the study, participants 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
Efficacy
Statistical methods / analysis
Quantitative data analysis:
Descriptive statistics will be used to describe the characteristics of the sample by group (means [SD], 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.

Compliance with 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.

Functional activity 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.

Sample Size:
We aim to recruit 50 participants. While there are no clear guidelines on the sample size required for feasibility studies this size should enable the primary aim of feasibility to be addressed.

Qualitative data analysis:
Interviews will be audiotaped and records of all interviews will be transcribed. Any identifying information will be removed and each transcript assigned a number for further analysis.

Qualitative analysis of transcripts will be undertaken by two investigators independently, using qualitative data management software. The de-identified transcripts will be read by each investigator and codes devised to represent the data. Codes will be reviewed and emerging themes will be developed through a process of collapsing codes together and defining categories, using an interpretive descriptive approach. Consensus between the investigators on the emerging themes and categories will be achieved through discussion.
Following the interview, each participant will be sent a copy of their transcript for correction, clarification and further comment, to maximize accuracy of the data (a process termed ‘member checking’). All identifying information in the transcript will be removed following member checking.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/09/2020
Actual
22/02/2021
Date of last participant enrolment
Anticipated
21/02/2022
Actual
8/02/2022
Date of last data collection
Anticipated
1/02/2023
Actual
1/02/2023
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16821 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 30444 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 305861 0
Hospital
Name [1] 305861 0
Peninsula Health
Country [1] 305861 0
Australia
Primary sponsor type
Hospital
Name
Peninsula Health
Address
2 Hastings Road
Frankston
VIC 3199
Country
Australia
Secondary sponsor category [1] 306311 0
None
Name [1] 306311 0
Address [1] 306311 0
Country [1] 306311 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306121 0
Peninsula Health Human Research Ethics Committee
Ethics committee address [1] 306121 0
Ethics committee country [1] 306121 0
Australia
Date submitted for ethics approval [1] 306121 0
27/03/2020
Approval date [1] 306121 0
21/05/2020
Ethics approval number [1] 306121 0
HREC/63005/PH-2020-212635(v2)

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

Contacts
Principal investigator
Name 102782 0
Dr David Snowdon
Address 102782 0
Peninsula Health
2 Hastings Road
Frankston
VIC 3199
Country 102782 0
Australia
Phone 102782 0
+61 3 9788 1727
Fax 102782 0
Email 102782 0
dsnowdon@phcn.vic.gov.au
Contact person for public queries
Name 102783 0
David Snowdon
Address 102783 0
Peninsula Health
2 Hastings Road
Frankston
VIC 3199
Country 102783 0
Australia
Phone 102783 0
+61 3 9788 1727
Fax 102783 0
Email 102783 0
dsnowdon@phcn.vic.gov.au
Contact person for scientific queries
Name 102784 0
David Snowdon
Address 102784 0
Peninsula Health
2 Hastings Road
Frankston
VIC 3199
Country 102784 0
Australia
Phone 102784 0
+61 3 9788 1727
Fax 102784 0
Email 102784 0
dsnowdon@phcn.vic.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Anyone who wishes to access it.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Unrestricted access via supplementary file of publication.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8136Study protocol    Study protocol including statistical analysis plan... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFeasibility of allied health assistant management of people with acute hip fracture: Protocol for a feasibility randomised controlled trial.2021https://dx.doi.org/10.1136/bmjopen-2021-054298
N.B. These documents automatically identified may not have been verified by the study sponsor.