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Trial registered on ANZCTR


Registration number
ACTRN12624000886583
Ethics application status
Approved
Date submitted
2/07/2024
Date registered
19/07/2024
Date last updated
19/07/2024
Date data sharing statement initially provided
19/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Hospital in the home for hip fracture patients : a feasibility study
Scientific title
Hospital in the home for hip fracture patients (HITH4HIPs): a feasibility study
Secondary ID [1] 312429 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip fracture 334245 0
Condition category
Condition code
Injuries and Accidents 330908 330908 0 0
Fractures
Musculoskeletal 330909 330909 0 0
Osteoporosis
Public Health 330910 330910 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Setting: The Orthopaedic Department is rolling out a new pathway within its hip fracture care pathway. It is adding a hospital in the home (HITH) component for patients who fit the criteria for eligibility. As per the NSW Health HITH Guidelines, patients involved in HITH programs must consent to the intervention. The Intervention is NOT a research intervention; it is a clinical intervention; if patients who are eligible decline the intervention, they receive usual care. The research component involves following hip fracture patients regardless of whether they accept or decline the program. Patients do not enroll in the study per se; monitoring of patients to at least 6-weeks post-admission is routine at our facility, including the review of such data by researchers. The program will be reviewed over a 5-6-month period, resources permitting. The final patients to be reviewed in the program will be admitted before 24th December 2024, thus their 6-week follow-up will be in January 2025.
HITH-accepted Group: A hospital in the home (HITH) program is being added to the usual hip fracture care pathway as an alternative model of care for appropriate patients..
This group includes people who meet the eligibility criteria for a HITH program and who consent to participate in the HITH program after discussion with the treating team. Patients and carers are given information about the program, to help them decide whether a HITH program is suitable for them.

Once the person meets the criteria for transfer to the HITH program (this is expected to occur at a minimum 3-4 days after surgery), the person/participant will be transferred to their home. As per the clinical pathway for HITH, HITH staff (comprising a multidisciplinary team, MDT) will review the patient each day (in person and/or over the telephone as appropriate) and provide care that is comparable to that which would have been provided had the person stayed in a physical hospital ward bed. The MDT comprises a full-time physiotherapist, and part-time nurse and occupational therapist. Medical input is provided by the treating team, but reviews by medical staff occur either virtually or via a hospital-based clinic if required. After-hours, patients/carers are requested to contact the hospital, their local doctor or an ambulance depending on the urgency of the problem. The participant will be discharged from the program according to the same criteria used to discharge a patient from usual care (physical hospital ward).
Researchers will review the medical record to extract length of stay in the HITH program, number of HITH visits by staff, complications and any additional healthcare resource use. .
Intervention code [1] 328935 0
Rehabilitation
Comparator / control treatment
Usual care (HITH-declined gp): This group includes individuals people who are eligible for the HITH program as above, but who decline participation.
Usual care comprises the typical multi-disciplinary care that is provided by both acute-care wards and subacute/rehabilitation wards as required. Patients participating in this pathway will be discharged home once they meet the criteria for discharge, which include the ability to mobilise safely and function at home with available assistance and; the absence of active medical issues requiring ongoing in-hospital specialist input..
Control group
Active

Outcomes
Primary outcome [1] 338671 0
HITH Program eligibility rate
Timepoint [1] 338671 0
End of the observational period (after 5 months) - December 2024
Primary outcome [2] 338672 0
HITH Program consent rate
Timepoint [2] 338672 0
End of the observational period (5 months) - December 2024
Primary outcome [3] 338673 0
Successful HITH transfer rate
Timepoint [3] 338673 0
End of the observational period (5 months) - December 2024
Secondary outcome [1] 436957 0
Program acceptability
Timepoint [1] 436957 0
Within 1-3 days following program discharge
Secondary outcome [2] 436958 0
Acute length of stay
Timepoint [2] 436958 0
End of acute-care bed stay.
Secondary outcome [3] 436959 0
Total length of stay
Timepoint [3] 436959 0
End of total episode of care (at discharge from HITH (HITH group) or physical hospital (usual care))
Secondary outcome [4] 436960 0
Discharge destination
Timepoint [4] 436960 0
End of episode of care
Secondary outcome [5] 436961 0
Service costs of the program or usual care
Timepoint [5] 436961 0
End of the episode of care (i.e after HITH discharge or discharge from the physical hospital)
Secondary outcome [6] 436962 0
Hospital acquired complication
Timepoint [6] 436962 0
- End of total episode of care (with a breakdown for where and when (HITH period vs subacute)
Secondary outcome [7] 436965 0
Hip pain score at rest
Timepoint [7] 436965 0
Daily until discharge from hospital (discharge from HITH or usual care)
Secondary outcome [8] 436966 0
Fear of falling
Timepoint [8] 436966 0
Within 1-3 days after discharge from the program (HITH or usual care)
Secondary outcome [9] 436967 0
Hip pain score on movement
Timepoint [9] 436967 0
Daily until the end of program (either HITH program or usual care)
Secondary outcome [10] 436968 0
Opioid use
Timepoint [10] 436968 0
Daily over the entire episode of care (period of hospitalisation including HITH period). There will be capacity to break this down further into when (HITH vs subacute)
Secondary outcome [11] 436969 0
Health-related quality of life "today' score. Obtained via telephone call.
Timepoint [11] 436969 0
Within 1-3 days of discharge from hospital (either after HITH discharge or discharge from physical hospital)
Secondary outcome [12] 436970 0
Health related quality of life domains
Timepoint [12] 436970 0
Within 1-3 days of discharge from the program (either HITH or usual care)
Secondary outcome [13] 436971 0
Adequacy of pain relief
Timepoint [13] 436971 0
Within 1-3 days of discharge from the program (HITH or usual care)
Secondary outcome [14] 436972 0
Carer burden
Timepoint [14] 436972 0
Within 1-3 days of discharge from the program (HITH or usual care)
Secondary outcome [15] 436973 0
Use of community care services
Timepoint [15] 436973 0
6-weeks after initial admission to hospital
Secondary outcome [16] 436974 0
Health-related quality of life
Timepoint [16] 436974 0
6-weeks after initial admission
Secondary outcome [17] 436975 0
Mobility
Timepoint [17] 436975 0
6-12 weeks after initial admission. Note this time point is protracted for this measure because despite being booked for review at 6-weeks post-admission, actual presentation in person to the clinic varies.

Eligibility
Key inclusion criteria
- Community-dwelling adults aged => 50 years presenting to Liverpool Hospital with a low-trauma (osteoporotic) hip fracture who undergo surgical management.
- Frailty score of 6 or less (moderate frailty) based on the Clinical Frailty Score 1-9
- Anticipated to return to community (private) residence.
- Permitted to weight-bear as tolerated
- Carer available and is willing to help the patient with the HITH program
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Presence of other fractures that would delay discharge.
- Residential location outside the Liverpool and Fairfield Local Government Area.
- Private health insurance.
- Active end-of-life management or palliative care.
- Presence of other impairments which preclude early return home (e.g. significant hemiparesis, complex or disruptive renal dialysis needs, history of daily falls pre-admission, catastrophic complication perioperatively)
- Fracture occurred whilst in hospital for another reason
- Planned return or transfer to a residential aged care facility

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The researchers do not assign treatment pathway at all. Patients receive the HITH pathway of clinically indicated and they and their carer agree to the pathway.
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
This is a feasibility study and will not be powered to detect statistically significant between-group differences. We expect approximately 15-25 people will consent to the HITH Program over the prospective study period. A similar number or more is expected to be in the HITH declined group. The HITH group outcomes will be compared to patients eligible for HITH but who refused. Descriptive statistics (e.g. mean, standard deviation, medians, range, proportions) will be used to describe the cohort and the contextual variables. For the primary (feasibility) outcomes, the following criteria (i-iii) will need to be met to conclude that the program and or a definitive trial is feasible:
I. A minimum 40% screened are eligible for HITH
II. A minimum 30% eligible consent to HITH
III. Most (>50%) of those eligible have a successful HITH Transfer

Group differences (plus 95% CI) will be reported for secondary outcomes.

It is anticipated that the difference in total LOS and/or EuroQol VAS Today score (within 1-3 days of discharge) between the HITH Consented group and HITH Refused group will be used for determining the sample size required for a definitive trial if such a program is deemed feasible for the population.

Note - Daily pain scores are inconsistently recorded in the medical records for people in hospital under usual care conditions. Usual care daily pain scores will only be reported if at least 75% of this group has a pain score recorded daily. Higher compliance with recording pain scores is expected in the HITH group due to the use of specifically trained staff.

A qualitative study of stakeholders will be conducted alongside this observational study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/07/2024
Actual
Date of last participant enrolment
Anticipated
24/12/2024
Actual
Date of last data collection
Anticipated
15/03/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26742 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 42790 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 316841 0
Hospital
Name [1] 316841 0
Liverpool Hospital
Country [1] 316841 0
Australia
Funding source category [2] 316843 0
Other Collaborative groups
Name [2] 316843 0
SPHERE - Sydney Partnership for Health Education Research and Enterprise
Country [2] 316843 0
Australia
Funding source category [3] 316844 0
Charities/Societies/Foundations
Name [3] 316844 0
Liverpool Catholic Club
Country [3] 316844 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Hospital
Address
Country
Australia
Secondary sponsor category [1] 319078 0
None
Name [1] 319078 0
Address [1] 319078 0
Country [1] 319078 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315609 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 315609 0
https://www.swslhd.health.nsw.gov.au/ethics/
Ethics committee country [1] 315609 0
Australia
Date submitted for ethics approval [1] 315609 0
02/02/2024
Approval date [1] 315609 0
11/03/2024
Ethics approval number [1] 315609 0

Summary
Brief summary
The study was approved via the Low or Negligible Risk review pathway.
It is recommended practice when introducing a new model of care or a new element into a model of care, that it be evaluated properly. In this study, we will observe the effect of the new addition to the clinical pathway - a hospital in the home or HITH program.
HITH programs have been included as part of management pathways after low-trauma (osteoporotic) hip fracture since the late 1970s in the United Kingdom. HITH programs are a priority for NSW Health, but their uptake appears to be limited by available resources and published documentation of their effect. In trialling a HITH program here, we aim to establish whether such a program is feasible/practical in our patients. We are not testing a hypothesis, but we will specifically monitor program uptake/acceptance by patients/carers and safety. If the program is feasible, it is hoped its continuation (plus or minus any refinements) are supported by the organization.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135238 0
Prof Justine Naylor
Address 135238 0
Orthopaedic Dept. Liverpool Hospital, Locked bag 7103
Country 135238 0
Australia
Phone 135238 0
+61 02 8738 9257
Fax 135238 0
Email 135238 0
[email protected]
Contact person for public queries
Name 135239 0
Justine Naylor
Address 135239 0
Orthopaedic Dept. Liverpool Hospital, Locked bag 7103
Country 135239 0
Australia
Phone 135239 0
+61 02 8738 9257
Fax 135239 0
Email 135239 0
[email protected]
Contact person for scientific queries
Name 135240 0
Justine Naylor
Address 135240 0
Orthopaedic Dept. Liverpool Hospital, Locked bag 7103
Country 135240 0
Australia
Phone 135240 0
+61 02 8738 9257
Fax 135240 0
Email 135240 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?
Patient data (anthropometric, sociodemographic, comorbidity, or outcome data (LOS, complications)) that is stored in the Redcap database can be shared. It is anonymized. The dictionary will accompany any database.
When will data be available (start and end dates)?
Dec 2025 - Dec 2030
Available to whom?
Researchers upon reasonable request
Available for what types of analyses?
Reviews (eg patient-level meta-analysis). Though the study design (observational) may render the data ineligible for most reviews.
How or where can data be obtained?
From the primary investigator or their representative via the Orthopaedic Department, Liverpool Hospital
[email protected]


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.