Geriatric Hip Fractures Caregiver Programme

'Home Sweet Home' Programme: Empowering the Patient and Caregiver for Early and Safe Discharge of Patients With Geriatric Hip Fractures

Objective:

To study whether fracture hip patients can be benefited from the empowerment program

Hypothesis to be tested Primary hypothesis: empowerment program can improve the patient's functional recovery.

Secondary hypothesis: the program can improve readmission rate, length of stay, and secondary fracture.

Design and subjects This is a prospective randomised controlled trial and subjects are fracture hip patients

Instruments Ipads are needed to show the videos of the rehabilitation program

Interventions

The empowerment program consists of three main areas which directly correspond to the contents that the patients and caregivers expressed as most needed in interviews conducted by the investigators during hip fracture patients' follow up:

• Knowledge of the disease
• Confidence and skills in self-care management
• Support in the post-discharge period

Main outcome measures

Primary outcomes:

Functional scores (Modified Barthel Index and EQ-5D-5L) at the first follow-up visit (3 months postop).

Timed-up-and-go test at follow-up at 6 months and 1 year.

Secondary outcome:

Cumulative readmission rates at 1 month, 6 months, and 1 year The length of stay in the convalescent hospital Subsequent injury with fractures within 1 year

Data analysis Chi-square test is used for categorical variables. For continuous variables, the normal distribution is determined by the Kolmogorov-Smirnov test. Independent t-test is used for comparing average values of normally distributed continuous variables, while the Wilcoxon rank sum test is used for comparing median values of abnormally distributed variables.

Binary logistic regression is used to determine predictive factors for outcomes. Multivariate analysis is performed to verify independent predictive factors for outcomes.

Expected results Fracture hip patients can be benefited from the empowerment program.

Study Overview

• Status: Recruiting
• Conditions: Geriatric Hip Fracture
• Intervention / Treatment: Behavioral: Empowering the patient and caregiver for early and safe discharge of patients with geriatric hip fractures

Detailed Description

Introduction:

Health care consequences of hip fracture The global incidence of geriatric hip fractures is projected to increase by more than 250% in the next twenty-five years. Local data showed that there was a steady increase from 3500 to more than 4500 hip fractures per year from 2000 to 2011. Nevertheless, the consequence of hip fractures is serious and costly. Ten percent of patients have a contralateral hip fracture, 30% of the patients are readmitted for other acute reasons, 25% need long-term care, 10-25% die within 1 year and almost 50% have residual functional disabilities.

Geriatric hip fracture clinical pathway decreased preoperative length of stay Since 2006, the geriatric hip fracture clinical pathway (GFH) has been implemented in the Hong Kong West Cluster. The implementation of GFH resulted in a decreased preoperative length of stay, decreased surgical site infection, decreased pressure sore, and decreased 30-day and 12-month mortality rate.

High dependency of patients upon discharge:

However, according to our data, a significant number of patients still required an extended length of stay, which is defined as more than 28 days in a rehabilitation hospital. More than 60% of the patients were discharged home, however, 39% and 51% of the patients had severe and moderate dependency respectively upon discharge from the rehabilitation hospital (Modified Barthel Index 0-60 and 61-90 respectively). Current training provided to those patients and their caregivers was brief and inadequate. The lack of a trained caregiver affects the decision to return home and patients may need settlement in nursing homes. Moreover, 12% had readmission within 28 days of discharge, with repeated falls accounting for the majority.

The patients were referred to a geriatric day hospital after discharge from the convalescent hospital. However, the waiting time for geriatric day hospital was 2 months. During this interval, the patients were discharged home and taken care of by the caregivers. The caregivers were unsupported and inadequately trained for the job.

Patient and caregiver empowerment for hip fracture patients in Hong Kong:

Patient empowerment has been used in patients with stroke and other geriatric conditions. There are only scarce studies focussing on geriatric hip fractures which required special care in terms of ambulation, transfers, and activities of daily living training. So far prospective randomized studies are lacking. A previous study showed patient empowerment resulted in a shortened length of stay and earlier return to previous living by comparing two hospitals.

In Hong Kong, the elderly hip fracture patients returning home are often taken care of by domestic helpers or family members. Caring for older patients after hospital discharge is challenging and many of their caregivers lack the confidence to do so. Hence, we opine that caregivers need special attention as well. Another study also studied the caregivers' burden of hip fracture patients in Taiwan. The caregivers experienced moderate burdens. Caregivers who could not access other resources for help experienced a higher burden.

There has been an increasing trend for patient and caregiver empowerment programs. A study done by Hendrix (2013) investigated the effects of an individualized caregiver training program on self-efficacy in-home care and symptom management. Results revealed a significant increase in self-efficacy after the training in the treatment group, however, their study focused on cancer patients only. Another study done by Coleman in the year 2004 tested whether an intervention designed to encourage older patients and their caregivers to assert a more active role during discharge could result in decreased rehospitalization rates. He showed the adjusted odds ratio comparing rehospitalization of intervention subjects with that of controls was 0.52 at 30 days, 0.43 at 90 days, and 0.57 at 180 days. Intervention patients reported high levels of confidence in obtaining essential information for managing their condition, communicating with members of the healthcare team, and understanding their medication regimen. Their patient population is heterogeneous and includes various medical and orthopaedic patients.

Most studies on patient and caregiver empowerment had shown positive results. The proposed study focuses on empowering hip fracture patients and their caregivers in all aspects in terms of ambulation, transfers, and activities of daily living training. The impact of empowerment on hip fracture patients and their caregivers has not been studied in Hong Kong and the aim of the project is to investigate if those fracture hip patients can be benefited from the empowerment program in terms of functional outcomes.

• Study Type: Interventional
• Enrollment (Anticipated): 142
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathine Ching; Phone Number: 22554466; Email: kathine@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital, the University of Hong Kong
    • Contact: Kathine Ching; Phone Number: 22554466; Email: kathine@hku.hk
    • Principal Investigator: Tak Man Wong
    • Sub-Investigator: Frankie Ka Li Leung
    • Sub-Investigator: Christian Xinshuo Fang
    • Sub-Investigator: Dennis King Hang Yee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥65
2. Acute intracapsular or extracapsular proximal femur fracture
3. Surgical treatment: Hemiarthroplasty or reduction-internal fixation
4. Availability of caregiver

Exclusion Criteria:

1. No caregiver support
2. Non-operative treatment
3. Pathological fracture
4. Multiple fractures
5. Patient discharged directly from the acute hospital without convalescence 6. Premorbid bedbound/chairbound status

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group	Behavioral: Empowering the patient and caregiver for early and safe discharge of patients with geriatric hip fractures; Orthopaedic surgeon, geriatrician, physiotherapists, occupational therapists, and nurses will make videos (each 3-5 minutes long) which are available to the patients and caregivers during both the hospitalization period and after discharge. They will complement the therapists' training sessions and allow revision of the contents by the patients and caregivers anytime. The patients and caregivers will be asked to complete an assessment after they view the videos to reinforce the knowledge they learn in the videos. Caregivers can be patient's relatives, friends or domestic helper who can commit to visiting the patient at least two days per week during the early discharge period.
No Intervention: Standard Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional scores	Modified Barthel Index	First follow up visit (3 months postop)
Functional scores	EQ-5D-5L	First follow up visit (3 months postop)
Walking function	Timed-up-and-go test	6 months
Walking function	Timed-up-and-go test	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Cumulative readmission rates	1 month after hip surgery
Cumulative readmission rates	6 months after hip surgery
Cumulative readmission rates	2 years after hip surgery
The length of stay in convalescent hospital	Up to discharge back to home
Number of subsequent injury with fractures	within 2 years

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Tak Man Wong, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2019
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Caregiver; Empowerment; Geriatric Hip Fractures; Functional outcomes
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: UW 19-574

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No