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Trial registered on ANZCTR


Registration number
ACTRN12624000730505
Ethics application status
Approved
Date submitted
23/04/2024
Date registered
14/06/2024
Date last updated
14/06/2024
Date data sharing statement initially provided
14/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing the effectiveness and cost-effectiveness of Bounce Back, a tailored action-oriented discharge planning intervention for older hip fracture patients: A randomised controlled trial
Scientific title
Testing the effectiveness and cost-effectiveness of Bounce Back, a tailored action-oriented discharge planning intervention for older hip fracture patients: A randomised controlled trial
Secondary ID [1] 312023 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neck of femur fracture (Hip fracture) 333626 0
Condition category
Condition code
Injuries and Accidents 330312 330312 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
‘BOUNCE BACK’ INTERVENTION
The ‘Bounce Back’ intervention is a tailored, action-oriented discharge planning intervention. It includes four components. These include: the patient and/or support person meeting with an the Orthogeriatric Clinical Nurse Consultant (CNC) to introduce the program and explain the importance of adhering to the program; provision of two copies of an individualised discharge care plan booklet with instructions for accessing the series of online microlearning knowledge enhancement modules; a GP letter informing them of the program; and a reminder letter sent to the patient three weeks following discharge.

The intervention period will be 12 months. Patients will be encouraged to view the intervention modules within the first three weeks following discharge, however they will be able to view them at any point in the trial period. The primary endpoint will be 4 months following discharge; however, data will be collected at 12 months to explore the longer-term effects of the intervention. Loss to follow-up will be minimised by (a) obtaining multiple contact details for each participant, and (b) requesting the details of a stable secondary contact who does not reside with the participants.

Component 1. Research CNC involvement with the Individualised discharge care plan. Within the 48 hours prior to discharge, the Orthogeriatric Clinical Nurse Consultant (CNC) will meet with the patient and their support person to discuss the ‘individualised discharge care plan’. This meeting will be approximately 30 minutes in duration. Aboriginal participants who are allocated to the intervention group will be able to request to have an Aboriginal Liaison Officer present during their meeting, where possible.
The CNC will provide the patient with a ‘individualised discharge care plan’ signed by a member of the Orthogeriatrics team. The Discharge care plan provides an overview of the Bounce Back program, and emphasises the value of adhering to the offered treatment regime. The plan will include:
- an overview of the recommended behaviours within the treatment regimen and information about the importance of adhering to them.
- Information about the individualised discharge care plan booklet “Your Hip Fracture Care Plan” (see component 2), and describe the importance of the patient and support person completing all core modules in this booklet.
- instructions for accessing the online microlearning knowledge enhancement modules (see Component 2). Contact details for a research team member will be provided in case the patient or support person has difficulty accessing the online modules.
- recommendation to access additional modules depending on the patient’s individual circumstances. To identify which modules are relevant, a member of the Orthogeriatrics team will ask the patient to complete a brief checklist about concerns they might have in the post-discharge period, including returning to driving, returning to exercise, and lacking social support. To assess intervention fidelity, the proportion of patients allocated to the intervention condition who complete the checklist will be assessed.
- importance of going to see their GP within 3 weeks of discharge from hospital.
A member of the Orthogeriatrics team will be provided with a discharge care plan template and will tailor the content according to checklist responses and other individual circumstances. Once tailored, a member of the Orthogeriatrics team will provide the plan to the patient and their support person. A member of the Orthogeriatrics team will advise patients and their support persons that utilising the program is completely voluntary and that they will continue to receive high quality care regardless of whether they decide to take part in the program.

Component 2. Provision of two copies of the individualised discharge care plan booklet and online microlearning knowledge enhancement modules
Patients and their support persons will be provided with two copies of an individualised discharge care plan booklet, “Your Hip Fracture Care.”
The booklet includes a series of modules with information about hip fracture recovery. These modules will provide easy to understand, credible and relevant information. Content will be guided by the literature and best practice clinical guidelines, and from results of patient surveys that were completed post discharge with a neck of femur fracture. All patients will be instructed to complete core modules which contain essential information and prescribe ‘target behaviours’ for the post-discharge period. Target behaviours will be those that are associated with reduced risks of falls and hospital re-presentations (e.g., attendance at a falls prevention program). Participants will be encouraged to complete optional modules, which the Research CNC has identified are relevant to their individual circumstance. Each module will take less that 10 minutes to read.
The discharge care booklet contains the following modules.
Core Modules:
1. Managing my pain (How much pain to expect, How medications can be used to manage pain, Other strategies to manage pain)
2. Looking after my bones (Supplements and infusions, Refracture prevention clinic appointments and bone density scan, Nutrition, exercise, avoid smoking, limit alcohol)
3. Nutrition after a hip fracture (Risks of malnourishment after a hip fracture, What can be done to restore nutrition following hip fracture)
4. Reducing my risk of falling (Stepping on program, falls prevention clinic, NSW Active and Healthy Website)
5. Managing at home (How to manage getting around the home while your hip is healing, How to manage the house work or gardening, How to get more help if needed)
6. How my GP can help (How can your GP help you to recover, Strategies to avoid future falls, What to do make sure you get the most out of appointments with your GP)
7. Remembering what I need to do (How to sure you are following everything the doctors told you to do during your hospital stay, How to build self-efficacy)
8. Getting my confidence back (How to get back confidence back after a fall, How to deal with set-backs during recovery)
Optional Modules:
9. Getting more support at home (How a social worker can assist and how to obtain this assistance)
10. Getting back into exercise (signs of readiness to return to physical activity, type of physical activity that are most appropriate when recovering from hip fracture, Types of activities to avoid to prevent exacerbation)
11. Coping with fatigue (Strategies for managing fatigue)
12. Understanding delirium (Being able to recognise signs of delirium and who to contact if delirium is suspected,)
13. Returning to driving (Understanding how long it may take to return to driving again, Signs of being ready to drive again and the process for planning a return to driving, Making arrangements for transport in the interim)
14. Advance care planning (Understanding the importance of planning ahead and type of documents required)
15. Dealing with loneliness or isolation (Understanding the negative consequences of social isolation and where to go to get help)
16. Depression and anxiety following hip fracture (Why we need to look after our mental health and wellbeing following hip fracture surgery, How to tell if you experiencing anxiety or depression and who to speak to, What if you had pre-existing depression or anxiety before your hip fracture)
The “Your Hip Fracture Care” booklet will also include a web URL and QR code that links to a website which displays a series of online microlearning modules, accessible via computer, tablet or smart phone. The microlearning modules are short educational videos presented by a relevant clinician, between 3-6 minutes in length, supplemented by subtitles and diagrammatic representations of information. Participants will be encouraged to watch these microlearning videos to learn further information.
If the patient or their support person has internet access on the ward either via smartphone or tablet, they will be advised to watch the modules while in hospital, prior to discharge, and to complete the remainder at home. Patients who do not have internet access on the ward will be encouraged to start the modules as soon as possible when they arrive home.
Adherence will be measured through self-report on the surveys. Patients will be encouraged to read the booklet and watch the online modules within the first two weeks post discharge. They will be encouraged to return to the modules as often as required to refresh their memory about information they may have forgotten.
Component 3. GP Letter about the program. The patient/carer will be provided with a letter at recruitment to provide to their GP at their next appointment. This will contain: (i) basic information on the study and that patients will be advised to discuss topics or management from the booklet and modules (ii) a link to an electronic copy of the Your Hip Fracture Care Plan booklet and the online microlearning modules. GPs will be advised to only share/discuss the microlearning modules with the patient/s that has provided the letter/s to minimise the risk of contamination. The research team will provide a member of the Orthogeriatrics team with a template for this letter which can be tailored as needed according to individual circumstances.
Component 4. Follow-up letter sent from orthogeriatrics team to patient and support person. Three weeks following discharge from the acute admission, the patient and the support person will receive a tailored reminder letter from the orthogeriatrics team. Three weeks was selected to allow sufficient time for patients who have been discharged to a rehabilitation facility to return home. The letter will again summarise the information included in their prescription letter. It will highlight the list of treatment recommendations the person received, and the timeframe in which this action should be achieved. Recommendations for what should occur if the actions have not been taken will be highlighted, pointing out the benefits for the patient and their support person. Patients will be advised that if they are experiencing any difficulties or barriers to completing these actions, they should make an appointment to see their GP.

The primary endpoint will be 4 months following discharge; however, data will be collected at 12 months to explore the longer-term effects of the intervention.
Intervention code [1] 328468 0
Rehabilitation
Intervention code [2] 328469 0
Treatment: Other
Comparator / control treatment
Usual Care is defined as receive standard Neck-of-femur fracture recovery care post-discharge from hospital. This involves care in the community with orthopedic, geriatric and allied health teams. The treatment plan is communicated verbally to the patient at various stages of the admission. The patient’s treating GP will receive a discharge summary within 48 hours of discharge. The details of the letter are not individualized.
Control group
Active

Outcomes
Primary outcome [1] 338063 0
Composite outcome: Number of Days Alive and Out of Hospital
Timepoint [1] 338063 0
120 days post-discharge, 4 month survey
Secondary outcome [1] 434352 0
Pain
Timepoint [1] 434352 0
4 and 12 months follow-up post-discharge
Secondary outcome [2] 434353 0
Functional assessment
Timepoint [2] 434353 0
4 and 12 months follow-up post-discharge
Secondary outcome [3] 434354 0
Falls
Timepoint [3] 434354 0
4 and 12 months follow-up post-discharge
Secondary outcome [4] 434355 0
Quality of Life
Timepoint [4] 434355 0
4 and 12 months follow-up post-discharge
Secondary outcome [5] 434356 0
Health care utilisation costs
Timepoint [5] 434356 0
4 and 12 months follow-up post-discharge

Eligibility
Key inclusion criteria
Eligible patients will be i) aged 65 years or over; ii) admitted to the participating hospital with their first neck of femur fracture; iii) planning to discharge either to a private residence or rehabilitation facility; iv) have internet access (either at home or another location) or have a support person that has internet access; v) English speaking; and vi) are physically and mentally well enough to provide informed consent, or have a support person who is able to provide consent on their behalf. Eligible support persons will be aged at least 18 years, and providing practical or emotional support to a patient.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients that are planned to be discharged to a Residential Aged Care Facility (RACF) will be excluded from the trial given there is significant variability in functional goals of care for residents of aged care facilities and ongoing care is typically managed by health professionals in these settings with minimal resident control over care. Patients being managed with palliative intent will also be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients (and their support person, if relevant) will be block randomised by month of admission to either the control (usual care) or intervention group. The allocation sequence will be generated by an independent statistician at the Clinical Research Design, IT and Statistical Support Unit of the Hunter Medical Research Institute. It will not be possible to blind Research Assistants and Orthogeriatrics CNC to group allocation. Research Assistants will advise patients and support persons of the group to which they have been allocated following baseline data collection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 260 per arm will give the study 90% power to detect a difference in days alive and out of hospital at 120 days between treatment arms of 0.3 standard deviations with a type 1 error rate of 5%. This calculation has allowed for a 10% inflation factor to account for potentially skewed nature of the outcome variable. Approximately 450 patients with hip fractures are seen at this site per year. We estimate that 70% of those patients will be eligible to participate in this study (315/yr), and 83% of these will agree to participate (261 patients/yr)"We estimate that 70% of those patients will be eligible to participate in this study (315/yr), and 17% will decline to participate (55 patients/yr), we anticipate that our target sample should be reached in 2 years, with 4 and 12 month follow ups being completed in 3 years.
Effectiveness: The number of days alive and out of hospital will be compared between treatment arms using a linear regression model. Independent variables will include stratification variables and treatment group. The regression coefficient corresponding to treatment arm will be presented together with 95% confidence intervals and Wald p-values. Model assumptions will be assessed by inspection of residual plots, bootstrapping or Huber-White Sandwich estimators of the standard errors will be used, if applicable. Secondary outcomes will be compared between treatment arms using a similar regression model.
Cost-effectiveness: A trial-based cost effectiveness analysis will be conducted from a health service perspective. The primary outcome will be Quality Adjusted Life Years (QALY) measured by the EQ-5D-5L. Costs will be prospectively identified, measured and valued and include all resources associated with the interventions, plus healthcare resource utilisation over the follow-up period. The costs will be summed and combined with the outcome measure, and the incremental cost-effectiveness ratio [ICER = (CostInt-CostCtrl)/(EffectivenessInt-EffectivenessCtrl)] calculated. Boot strapping will be conducted to obtain reliable uncertainty intervals from skewed data, and cost effectiveness acceptability curves calculated.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
520
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26470 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 42450 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 316371 0
Government body
Name [1] 316371 0
NMHRC Partnership Project
Country [1] 316371 0
Australia
Funding source category [2] 316372 0
Government body
Name [2] 316372 0
Hunter New England Local Health District
Country [2] 316372 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 318554 0
None
Name [1] 318554 0
Address [1] 318554 0
Country [1] 318554 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315179 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 315179 0
Ethics committee country [1] 315179 0
Australia
Date submitted for ethics approval [1] 315179 0
28/03/2024
Approval date [1] 315179 0
09/04/2024
Ethics approval number [1] 315179 0
2021/ETH01085, 163113

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133910 0
Dr Zsolt Balogh
Address 133910 0
John Hunter Hospital, Royal Newcastle Centre, Bone & Joint Institute, Level 3, Lookout Road, New Lambton Heights NSW 2305, Australia
Country 133910 0
Australia
Phone 133910 0
+61 2 4921 4259
Fax 133910 0
Email 133910 0
[email protected]
Contact person for public queries
Name 133911 0
Dr Kristy Fakes
Address 133911 0
Health Behaviour Research Collaborative, W4, HMRI Building, University Drive, Callaghan, NSW 2308
Country 133911 0
Australia
Phone 133911 0
+61 2 4042 0306
Fax 133911 0
Email 133911 0
[email protected]
Contact person for scientific queries
Name 133912 0
Dr Kristy Fakes
Address 133912 0
Health Behaviour Research Collaborative, W4, HMRI Building, University Drive, Callaghan, NSW 2308
Country 133912 0
Australia
Phone 133912 0
+61 2 4042 0306
Fax 133912 0
Email 133912 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Summarised data may be reported in publications, reports and presentations. All data will be presented in an aggregated and summarised form. Only aggregated results will be provided upon request.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.