Clinical trial NCT06980129: Rehabilitation in the Home After Hip Fracture
Official title: RITH4Hips - Rehabilitation in the Home After Hip Fracture
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hip Fractures (ICD-10 72.01-72.2)
Rehabilitation Program
Keywords: rehabilitation program
hip fracture
Lead sponsor: South West Sydney Local Health District
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 220
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a pragmatic, multicentre, randomised, single-blinded, two-group parallel, non-inferiority trial with an embedded qualitative component. Participants will be recruited in parallel from two different hospitals, ensuring a diverse and representative sample.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: Study Aim This study aims to determine whether a multidisciplinary Rehabilitation in the Home (RITH) program for patients following low-trauma hip fracture (LTHF) is non-inferior to inpatient rehabilitation in terms of mobility during activities of daily living (ADL), assessed using the de Morton Mobility Index (DEMMI)

Study Design This is a pragmatic, multicentre, randomised, single-blinded, parallel-group, non-inferiority clinical trial with an embedded qualitative component.

As part of recruitment monitoring, reasons for declining participation will be recorded for individuals approached but not enrolled.

Hypotheses

The investigators hypothesise that compared to inpatient rehabilitation, the RITH program will be:

Non-inferior in terms of mobility recovery (DEMMI score within 2.9 points). Superior in reducing hospital bed days, with at least a 6-day reduction in physical ward stay.

Superior in improving health-related quality of life, walking ability, fear of falling, opioid consumption, and carer experience.

More cost-effective than usual care. Effective in reducing total length of stay (LOS), provided barriers to rapid transition to RITH are addressed.

Methods

Eligibility is determined perioperatively.

Inclusion criteria

* Adults aged ≥50 admitted to Liverpool or Bankstown hospitals with LTHF who:
* Undergo surgical management.
* Were living in the community pre-injury and plan to return home.
* Weight bear as tolerated post-surgery.
* Are deemed suitable for rehabilitation.
* The presence of a carer, if required for mobility or function, is necessary at the time of transfer to the community. The carer must be prepared to manage the patient within 3 days post-randomisation.
* Suitable environment for home-based rehabilitation as assessed by the MDT as per usual practice.

Once cleared for rehabilitation (typically 5-10 days post-surgery), participants will be randomised to:

Intervention Groups

Usual Care Inpatient Rehabilitation (UCIR): Participants will receive care in a rehabilitation ward or subacute hospital, including therapy from a multidisciplinary team. Discharge occurs when they achieve sufficient walking and functional ability, typically within 1-3 weeks. Researchers will collect information about carer visits and associated costs during the stay.

Rehabilitation in the Home (RITH): Participants will receive therapy at home from a multidisciplinary team. Discharge occurs when they achieve sufficient walking and functional ability, typically within 1-3 weeks. Researchers will contact patients about carer-related costs during the program.

Follow-up Assessments:

After completing rehabilitation, researchers will visit participants at home (or in the clinic if preferred) shortly after discharge and again six weeks after their initial hospital admission to assess walking ability, daily activities, confidence, quality of life, pain, and post-surgery challenges. Researchers will also gather information on healthcare visits, costs, and new community services used. If participants have carers, the carers will be invited to complete a voluntary survey about carer experience. Medical records will also be reviewed to understand the care provided over the study period.

Qualitative study:

A purposive sample of patients and their carers who were randomised to the RITH group will be invited to participate in a one-on-one interview some weeks after completing rehabilitation. Additionally, an opportunistic sample of other stakeholders such as clinicians, healthcare managers, and insurers will be invited to participate. The embedded qualitative study seeks to gain insights into why the RITH program was or was not deemed effective for individual participants, as well as how the RITH program may be made more acceptable for future implementation.

Sample size calculation:

A sample of 220 participants (allowing for 7% loss to follow-up) is required to detect:

A 2.9-point between-group difference in DEMMI (non-inferiority margin: 6, SD: 8.9).

A 6-day reduction in hospital bed days (mean 25, SD 17, negative binomial parameter theta = 2.1) with 80% power (α = 0.05).

Analysis plan for primary outcome: The primary outcome will be analysed using an analysis of covariance (ANCOVA) with the 6-week DEMMI score as the dependent variable, and independent variables of group, timepoint, and an interaction between group and timepoint. The 6-week DEMMI will be examined using contrasts of the interaction.

Cost analysis: A cost-effectiveness analysis will be conducted alongside this trial, including both direct and indirect costs.

Analysis plan for qualitative study: Qualitative interviews will be analysed using the Rapid Assessment Process, combining deductive and inductive approaches for efficient thematic analysis.

Eligibility criteria: Inclusion Criteria:

* 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)
* The presence of a carer, if required for mobility or function, is necessary at the time of transfer to the community. The carer must be prepared to manage the patient within 3 days post-randomisation. This time frame is considered necessary as carers will not be able to complete all required preparations before randomisation, and allowing an extended preparation period could bias the length of physical ward bed stay for the RITH group
* Suitable environment for home-based rehabilitation as assessed by the MDT as per usual practice

Exclusion Criteria:

* 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

Primary outcomes:
measure: De Morton Mobility Index (DEMMI)
timeFrame: 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:
measure: Length of Stay (LOS) - Total
timeFrame: At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).
measure: Length of Stay (LOS) - Physical Ward Bed
timeFrame: At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).
measure: Index Hip Pain
timeFrame: 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.
measure: EuroQol-5D-5L (EQ5D)
timeFrame: 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.
measure: Timed Up-and-Go Test (TUG Test)
timeFrame: 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.
measure: Falls Efficacy Scale (FES)
timeFrame: 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.
measure: Zarit Carer Burden Interview (ZCBI)
timeFrame: At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).
measure: Positive Aspects of Caregiving Scale (PACS)
timeFrame: At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).
measure: Functional Independence Measure (FIM)
timeFrame: 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.
measure: Hospital-Acquired Complications (HACs)
timeFrame: At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).
Other outcomes:
measure: Quality-Adjusted Life Years (QALYs)
timeFrame: Assessments will be calculated at 6 weeks post-admission.
measure: Health Service Costs
timeFrame: 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.
measure: Participant and Carer Costs
timeFrame: 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.
measure: Incremental Cost-Effectiveness Ratio (ICER)
timeFrame: Assessments will be calculated at 6 weeks following initial hospital admission.
measure: Opioid Consumption
timeFrame: Assessments will occur daily through completion of the allocated rehabilitation program, starting on Day 1 and continuing until discharge (on an average duration of 14 days), and at 6 weeks following initial hospital admission.
Locations:
city: Sydney
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Fairfield Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Bankstown-Lidcombe Hospital
state: New South Wales
Study officials:
affiliation: South West Sydney Local Health District
name: Thuy Anh Bui, BSC, GradCert Higher Ed, PhD
role: PRINCIPAL_INVESTIGATOR
References: