NCT06980129

Rehabilitation in the Home After Hip Fracture

RITH4Hips - Rehabilitation in the Home After Hip Fracture

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: South West Sydney Local Health District · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hip Fractures (ICD-10 72.01-72.2)
• Rehabilitation Program

Interventions

Type	Name	Description
OTHER	Rehabilitation in the home	Participants 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.
OTHER	Usual care inpatient rehabilitation	Participants 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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-07-31
• Completion: 2027-09-20
• First posted: 2025-05-20
• Last updated: 2025-05-20

Locations

3 sites across 1 country: Australia