Rehabilitation in the Home After Hip Fracture
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorSouth West Sydney Local Health District
About this trial
Hip fractures are common, especially in older adults, and they can have a big impact on health and quality of life. In Australia, hip fractures are a significant healthcare challenge. After surgery, patients often need rehabilitation to regain mobility, but this usually involves long hospital stays. The RITH4Hips trial will determine if a program where patients receive rehabilitation at home (instead of in the hospital) is similar to conventional inpatient rehabilitation.
Objectives:
The main goal of this study is to find out if rehabilitation at home after surgery for a hip fracture works as well as rehabilitation in the hospital. The investigators also want to see if the home rehabilitation program can reduce the time spent in a hospital bed and improve other aspects like quality of life, mobility, and pain management.
Methods:
This study will involve older adults who have had surgery due to a low-trauma hip fracture. Participants will be randomly assigned to either the usual care inpatient rehabilitation or the Rehabilitation in the Home (RITH) program. The investigators will measure outcomes such as how well patients can move, how much pain they experience, how their quality of life improves, and how much time they spend in the hospital.
Expected Outcomes:
The investigators expect that the home rehabilitation program will be just similar to inpatient rehabilitation in helping patients recover mobility. The investigators also hope to find that it will reduce the time patients spend in a hospital bed, improve their quality of life, reduce fear of falling, and lessen the burden on carers. Additionally, the investigators aim to show that the home program is more cost-effective than hospital-based rehabilitation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Community-dwelling adults ages ≥ 50 years presenting to Liverpool hospital or Bankstown-Lidcombe hospital with a low-trauma (osteoporotic) hip fracture who undergo surgical management
Anticipated to return to community (private) residence
Permitted to weight-bear as tolerated post-surgery
Suitable for inpatient rehabilitation (i.e., requires multidisciplinary rehabilitation, is considered cognitively suitable by the MDT to participate in the rehabilitation program being examined, and would otherwise be admitted to inpatient rehabilitation)
Disqualifiers
Presence of a concomitant condition that precludes actively participating in a rehabilitation program at home
Residential location outside the Bankstown-Canterbury, Liverpool, and Fairfield Local Government Areas
Active end-of-life management or palliative care
Previously participated in the HITH4Hips or RITH4Hips trials
Trial design
Design model
Parallel
Treatments tested in this trial
Rehabilitation in the home
Other interventionParticipants will receive home-based therapy from a MDT team, including physiotherapists, occupational therapists, social workers, dietitians, medical practitioners, psychologists, and pharmacists. Participants will be transferred to RITH once they achieve a level of mobility (+/- assistance) that enables them to manage at home. As per usual care, the disciplines required, frequency of visits, duration of visits, and duration of rehabilitation will be based on the patient's specific needs. There will be weekly MDT conferences to discuss patient progress led by medical staff. Telehealth care may be incorporated into the RITH program, subject to patient preference and provider availability. If the participant deteriorates during the RITH program, the escalation plan mandated by the LHD HITH Department will be followed to ensure appropriate care is provided. As for UCIR, discharge occurs when patients achieve sufficient walking and functional ability with available assistance.
Usual care inpatient rehabilitation
Other interventionParticipants will receive care in a rehabilitation ward or subacute hospital, including therapy from a MDT team. Discharge occurs when patients achieve sufficient walking and functional ability with available assistance, typically within 1-3 weeks, though this varies.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Rehabilitation in the Home (RITH)Experimental treatment 1 intervention
Group B: Usual Care Inpatient Rehabilitation (UCIR)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
De Morton Mobility Index (DEMMI)
The De Morton Mobility Index is a mobility outcome measure specifically designed for an older population. The DEMMI assesses 15 tasks which are associated with activities of daily living such as bed mobility and sit-to-stand transitions. The DEMMI is scored between 0 - 100, where 0 represents no mobility and 100 represents full mobility. The Minimal Clinically Important Difference (MCID) for the DEMMI is estimated to be approximately 6 points, representing the smallest change necessary to reflect a clinically meaningful improvement in mobility.
Time frame
At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation) and at 6 weeks after initial admission.Secondary outcomes
1
Length of Stay (LOS) - Total
Number of days spent in the program, from acute admission until discharge from rehabilitation.
Time frame
At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).2
Length of Stay (LOS) - Physical Ward Bed
Number of days spent in a physical ward bed in the hospital (including both acute and subacute locations).
Time frame
At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).3
Index Hip Pain
Hip pain at rest, on movement, and maximum. Score is a numerical rating from 0 - 10, where 0 is no pain and 10 is the worst pain imaginable.
Time frame
Assessments will occur at baseline (within 24 hours prior to randomisation), daily during the allocated rehabilitation program (an average of 14 days from admission to rehabilitation), and at 6 weeks following initial hospital admission.4
EuroQol-5D-5L (EQ5D)
The EuroQol-5D-5L is a questionnaire used to measure patient's health-related quality of life. It assesses 5 domains related to mobility, self-care, usual activities, pain/discomfort and anxiety/depression and provides a score between 1 - 5 for each domain where 1 means no problems, and 5 means extreme problems.
Time frame
Assessments will be conducted at baseline (within 24 hours prior to randomisation), at 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation), and at 6 weeks post-admission.Other outcomes
1
Quality-Adjusted Life Years (QALYs)
QALYs will be derived from responses to the EQ-5D questionnaire administered at three timepoints: baseline (prior to randomisation), 1 to 3 days after discharge from the rehabilitation program, and 6 weeks post-admission. This measure will quantify patient health outcomes and quality of life over time, enabling the evaluation of the RITH program's impact on patient well-being.
Time frame
Assessments will be calculated at 6 weeks post-admission.2
Health Service Costs
The total episode of care cost to the health service will be assessed from the provider's perspective. Episode of care costs will be obtained directly from the hospital, while direct costs for each episode of care and episode of service will be sourced from the health service. All costs will be adjusted to 2025 values using the Gross Domestic Price Index.
Time frame
Health service costs will be assessed using data from each hospital's Finance Department, covering admission to the end of the allocated rehabilitation program (average 14 days post-rehab admission). Data will be available 8 to 12 weeks post-discharge.3
Participant and Carer Costs
Participant and carer costs will be collected through regular follow-ups and will include expenses such as costs for parking, transportation, home modifications, medication, and lost productivity due to time taken off work. These costs will capture the financial burden on both participants and their carers as part of the economic evaluation of the RITH program.
Time frame
Assessments will occur weekly during the allocated rehabilitation program (up to average 14 days from rehabilitation admission), and at 6 weeks following initial hospital admission.4
Incremental Cost-Effectiveness Ratio (ICER)
The ICER will be calculated as the cost per additional Quality-Adjusted Life Year (QALY) gained, comparing the health service cost and participant and carer costs of the RITH and UCIR programs. This measure will assess the cost-effectiveness of the RITH program by evaluating the economic impact relative to improvements in patient health outcomes.
Time frame
Assessments will be calculated at 6 weeks following initial hospital admission.Sponsors and contacts
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Source ClinicalTrials.gov
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