Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001442796
Ethics application status
Approved
Date submitted
27/10/2022
Date registered
11/11/2022
Date last updated
6/03/2023
Date data sharing statement initially provided
11/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
HIP fracture Supplemental Therapy to Enhance Recovery
Scientific title
HIP fracture Supplemental Therapy to Enhance Recovery: Investigating the effect on hospital length of stay for older adults with hip fractures
Secondary ID [1] 308008 0
Nil known
Universal Trial Number (UTN)
Trial acronym
HIPSTER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip fracture 327679 0
Condition category
Condition code
Musculoskeletal 324764 324764 0 0
Other muscular and skeletal disorders
Injuries and Accidents 325203 325203 0 0
Fractures
Physical Medicine / Rehabilitation 325204 325204 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will receive usual care physiotherapy as per the control treatment, plus two additional daily sessions. One session will be delivered by an allied health assistant, to practice the achievements of the usual care session. The other session will be delivered by a physiotherapist and targeted to the needs of the patient with the aim of progressing the functional gains achieved in the previous therapy session including increasing independence with mobility, progression of gait aid (e.g. frame to crutches) and increasing the distance walked. We anticipate that the sessions will be approximately 30 minutes each although will be targeted to the patient and their ability to participate. The sessions will be at least 2 hours apart to allow time for the patient to rest in between sessions. The intervention will be delivered for 7 days or until discharge from the acute ward, whichever occurs sooner. The occasions of service and length of each treatment session will be recorded to monitor adherence to the intervention.

Participants in the intervention group will also receive medical and surgical management according to best practice standards. Allied health interventions aside from physiotherapy (e.g. occupational therapy) will be delivered according to usual practice at each centre with all encounters recorded.

Intervention code [1] 324460 0
Treatment: Other
Intervention code [2] 324808 0
Rehabilitation
Comparator / control treatment
Participants will receive usual care physiotherapy according to usual practice at the site. Usual care treatment will be individualised and will likely include lower limb exercises, therapy aimed at regaining independence with transfers and mobility as well as gait re-training. The duration of the sessions will be dependant on the patient's ability to participate and will occur as per the usual practice at the centre across the weekdays and weekends.. The duration and number of sessions will be recorded.
Discharge planning will follow what usually occurs at the site, with the involvement of the usual care therapist.

Participants in the usual care group will also receive medical and surgical management according to best practice standards. All allied health groups (e.g. occupational therapy) will be delivered according to usual practice at each site.
Control group
Active

Outcomes
Primary outcome [1] 332586 0
Total hospital length of stay for the index admission in days, including both acute hospital days and rehabilitation hospital days. This will be collected via review of the medical records.
Timepoint [1] 332586 0
Discharge from the hospital stay, including rehabilitation/sub-acute care stay if that is the discharge destination from the acute hospital. T
Secondary outcome [1] 413990 0
Functional mobility measured with the Modified Iowa Level of Assistance Score (mILOA) via assessment by blinded assessor
Timepoint [1] 413990 0
At day 7 post-surgery
Secondary outcome [2] 414159 0
Health related quality of life measured with the EuroQol EQ-5D-5L via in person (day7) or telephone interview with participant
Timepoint [2] 414159 0
At day 7 (in person), 6 weeks, 120 days and 12 months post hip fracture surgery
Secondary outcome [3] 414160 0
Health related quality of life measured with the ICEpop CAPability measure for Older people (ICECAP-O) via in person (day 7) and telephone interview with participant
Timepoint [3] 414160 0
At day 7 , 6 weeks, 120 days and 12 months post hip fracture surgery
Secondary outcome [4] 414305 0
Falls efficacy measured with the Falls Efficacy Scale-International (FES-I) via telephone interview with participant
Timepoint [4] 414305 0
At day 7, 6 weeks, 120 days and 12 months post hip fracture surgery
Secondary outcome [5] 414306 0
Proportion of patients remaining in hospital assessed by medical records
Timepoint [5] 414306 0
At 6 weeks post hip fracture surgery
Secondary outcome [6] 414307 0
Return to preadmission mobility assessed by by Australian and NZ Hip Fracture Registry data and patient report - undertaken via telephone interview with the participant
Timepoint [6] 414307 0
At 6 weeks, 120 days and 12 months post hip fracture surgery
Secondary outcome [7] 414308 0
Survival assessed by Australian and NZ Hip Fracture Registry data and review of hospital records
Timepoint [7] 414308 0
At 6 weeks, 120 days and 12 months post hip fracture surgery
Secondary outcome [8] 414309 0
Participant current residence as assessed by by Australian and NZ Hip Fracture Registry data and patient-reported data via phone interviews with participant and a review of medical records
Timepoint [8] 414309 0
At 6 weeks, 120 days and 12 months post hip fracture surgery
Secondary outcome [9] 414310 0
Re-operation rate as assessed by by Australian and NZ Hip Fracture Registry data, patient-reported data via phone interviews with participant and a review of medical records
Timepoint [9] 414310 0
At 6 weeks, 120 days and 12 months post hip fracture surgery
Secondary outcome [10] 414775 0
Discharge destination from the acute ward assessed by Australian and NZ Hip Fracture Registry data and via review of hospital medical record
Timepoint [10] 414775 0
At discharge from the acute ward
Secondary outcome [11] 414776 0
Number of adverse events as defined by Good Clinical Practice (GCP) standards. Examples of adverse events may include inpatient falls or dislocation of hip prosthesis, as well as hospital readmission. This will be collected via via phone interviews with participant and a review of medical records
Timepoint [11] 414776 0
At 6 weeks, 120 days and 12 months post hip fracture surgery
Secondary outcome [12] 414777 0
Healthcare utilisation, assessed by patient-reported data via monthly telephone interview with participants as well as a phone call at 6 weeks, 120 days and 12 months, review of hospital records and Medicare Benefits Schedule (MBS) / Pharmaceutical Benefits Scheme (PBS) data
Timepoint [12] 414777 0
At 12 months following hip fracture surgery
Secondary outcome [13] 415325 0
Number of falls assessed by patient report via phone interviews with participant and a review of medical records
Timepoint [13] 415325 0
The data will be collated at 6 weeks, 120 days and 12 months post hip fracture surgery

Eligibility
Key inclusion criteria
Aged 65 years or older and admitted with an isolated subcapital or intertrochanteric hip fracture subsequently managed operatively
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if the fracture is subtrochanteric or pathological, if the postoperative orders require non-weightbearing on the operative hip, if unable to mobilise (with or without a gait aid) prior to fracture, or if living in nursing home or aged care facility.

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)
Central randomisation by phone or computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation with stratification for recruitment site
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
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
To detect a reduction in total hospital length of stay (natural log transformed) of mean 0.19 (equivalent to approx. 5 days), assuming a standard deviation of 0.8 with 80% power and a 2-sided 0.05 significance level, a total of 556 participants are required (278 each group). Allowing for 10% attrition we will recruit a total of 620 participants.

The primary outcome (total hospital length of stay) is expected to be positively skewed, and so is likely to be log transformed. Continuous outcomes will be analysed using linear mixed models, with the main explanatory variable being the intervention. The probability of remaining admitted at 30 days (and other data based on binary outcomes) will be analysed using logistic regression.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/01/2023
Actual
19/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
620
Accrual to date
29
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 312271 0
Government body
Name [1] 312271 0
Australian Department of Health Medical Research Future Fund (MRFF)
Country [1] 312271 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Level 6, The Alfred Centre, 99 Commercial Rd Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 313902 0
None
Name [1] 313902 0
Address [1] 313902 0
Country [1] 313902 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311645 0
Alfred Health
Ethics committee address [1] 311645 0
Ethics committee country [1] 311645 0
Australia
Date submitted for ethics approval [1] 311645 0
Approval date [1] 311645 0
29/08/2022
Ethics approval number [1] 311645 0

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

Contacts
Principal investigator
Name 121834 0
Dr Lara Kimmel
Address 121834 0
Alfred Hospital
Department of Physiotherapy
55 Commercial Road, Melbourne, VIC 3004
Country 121834 0
Australia
Phone 121834 0
+61 411260232
Fax 121834 0
Email 121834 0
[email protected]
Contact person for public queries
Name 121835 0
Eleanor Raper
Address 121835 0
Monash University
Level 6, The Alfred Centre, 99 Commercial Rd Melbourne VIC 3004
Country 121835 0
Australia
Phone 121835 0
+61 425208689
Fax 121835 0
Email 121835 0
[email protected]
Contact person for scientific queries
Name 121836 0
Lara Kimmel
Address 121836 0
Alfred Hospital
55 Commercial Road, Melbourne, VIC 3004
Country 121836 0
Australia
Phone 121836 0
+61 411260232
Fax 121836 0
Email 121836 0
[email protected]

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 for all outcome measures
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
To investigators who provide a methodologically sound proposal, with oversight of Alfred HREC
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Subject to approvals by Principal Investigator [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17237Study protocol  [email protected]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHIP fracture Supplemental Therapy to Enhance Recovery (HIPSTER): A protocol for a randomised controlled trial.2024https://dx.doi.org/10.1136/bmjopen-2023-079846
N.B. These documents automatically identified may not have been verified by the study sponsor.