Rehabilitation in the Home After Hip Fracture

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.

• Length of Stay (LOS) - Total [Time frame: At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).]
• Length of Stay (LOS) - Physical Ward Bed [Time frame: At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).]
• Index Hip Pain [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.]
• EuroQol-5D-5L (EQ5D) [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.]
• Timed Up-and-Go Test (TUG Test) [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.]
• Falls Efficacy Scale (FES) [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.]
• Zarit Carer Burden Interview (ZCBI) [Time frame: At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).]
• Positive Aspects of Caregiving Scale (PACS) [Time frame: At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).]
• Functional Independence Measure (FIM) [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.]
• Hospital-Acquired Complications (HACs) [Time frame: At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).]