Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000443796
Ethics application status
Approved
Date submitted
28/02/2022
Date registered
21/03/2022
Date last updated
23/02/2023
Date data sharing statement initially provided
21/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Uptake of rehabilitation-at-home following total hip and knee replacement surgery at a private hospital – a randomised controlled trial
Scientific title
The effect of a patient information intervention on uptake of rehabilitation-at-home following primary, elective total hip and knee replacement surgery at a private hospital – A randomised controlled trial
Secondary ID [1] 304724 0
None
Universal Trial Number (UTN)
U1111-1267-7648
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary, elective total hip replacement 325445 0
Primary, elective total knee replacement 325446 0
Condition category
Condition code
Musculoskeletal 322826 322826 0 0
Osteoarthritis
Surgery 322937 322937 0 0
Other surgery
Public Health 322938 322938 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Materials: A one page patient information 'nudge letter' (plus usual care) will be provided to participants

Content: The letter, designed specifically for this study, will contain behavioural change techniques of persuasive argument and shaping knowledge. The letter will contain lay language about the positive consequences of rehabilitation-at-home, statements that allay fears of home safety and burdening their caregiver, assurances about capability and confidence at home, and information from trusted source. The letter is personalised to individuals by including their specific surgery type (hip or knee replacement) and orthopaedic surgeon's name.

Mode of delivery and process: a research assistant will distribute the letter to participants individually via both mail and email, once prior to surgery. Strategies used to monitor adherence to/fidelity of the intervention, will include email read receipts and a follow-up email or telephone call.
Intervention code [1] 322978 0
Treatment: Other
Intervention code [2] 323081 0
Behaviour
Comparator / control treatment
Usual care - Participants allocated to the control group will not receive the intervention letter. Participants will receive usual care that includes the following components: pre-operative education and information, surgery and acute inpatient care, transitional care with referrals to hospital-at-home, rehabilitation-at-home, outpatient rehabilitation or inpatient rehabilitation. Some participants may also receive home care assistance such as social support, meals or shopping delivery and cleaning services.
Control group
Active

Outcomes
Primary outcome [1] 330611 0
Proportion of patients receiving non-inpatient rehabilitation (i.e., rehabilitation-at-home or outpatient rehabilitation) after discharge from the acute hospital. This outcome will be assessed as 'yes or no' by accessing routinely collected data from the private hospital database.
Timepoint [1] 330611 0
Assessed from the time of hospital discharge until 6 months post-surgery.
Secondary outcome [1] 406941 0
Total length of inpatient stay for inpatient care (days). This outcome will be assessed by accessing routinely collected data from the private hospital database.
Timepoint [1] 406941 0
Assessed from the time of hospital discharge.
Secondary outcome [2] 406944 0
Knee or hip pain assessed using a 10cm Visual Analogue Scale (0 to 10, 0 – ‘no pain’, 10 - ‘worst pain imaginable’).
Timepoint [2] 406944 0
Baseline (before surgery) and 6 months after surgery
Secondary outcome [3] 406945 0
Perceived change with their knee or hip since their surgery assessed using a 5-point Likert scale from ‘much better’ to ‘much worse’
Timepoint [3] 406945 0
6 months after surgery
Secondary outcome [4] 406947 0
Physical function assessed using the Oxford Knee or Hip Score (0 to 48, higher score indicates higher joint function)
Timepoint [4] 406947 0
Baseline (before surgery) and 6 months after surgery
Secondary outcome [5] 406949 0
Physical function assessed using the KOOS-12 or HOOS-12 (0 to 100, 100 indicates no symptoms and 0 indicates extreme symptoms).
Timepoint [5] 406949 0
Baseline (before surgery) and 6 months after surgery
Secondary outcome [6] 406951 0
Health-related quality of life using EQ-5D-5L with responses converted to utility scores (1 indicating the value of a perfect health state) and EQ-VAS, (0 = worst imaginable health, 100 = best imaginable heath).
Timepoint [6] 406951 0
Baseline (before surgery) and 6 months after surgery
Secondary outcome [7] 406960 0
Patient satisfaction with the procedure using a 5-point Likert scale from ‘very satisfied’ to ‘very dissatisfied’
Timepoint [7] 406960 0
6 months after surgery
Secondary outcome [8] 406962 0
Number of participants experiencing an adverse event, defined as hospital readmissions for any reason or re-operation within 28 days following surgery. This outcome will be assessed as 'yes or no' by accessing routinely collected data from the private hospital database.
Timepoint [8] 406962 0
28 days after surgery
Secondary outcome [9] 406968 0
Total costs of inpatient care, non-inpatient care, societal, employment productivity and costs of implementation. Cost parameters related to hospital inpatient care will be accessed using the private hospital database. Cost parameters related to non-inpatient care, societal costs and employment productivity will be collected by participant self-report using an electronic diary via the study’s Qualtrics website. Cost parameters related to implementation (e.g., mailing of the letters) will be a fixed cost.
Timepoint [9] 406968 0
3 months after surgery
Secondary outcome [10] 406969 0
Process outcome exploring factors that influenced the effectiveness of the intervention from the perspectives and experiences of participants using semi structured interviews, designed specifically for this study, that are audio recorded and transcribed verbatim.

A subset of participants will be selected using a purposive sampling approach with a mix of participants who received hospital-at-home, rehabilitation-at-home and inpatient rehabilitation, a mix of genders and a mix of participants who had someone living with them or not. Approximately 30 participants are expected to provide sufficient qualitative data (data saturation) to address this research question. After data saturation is reached, no further participants from the intervention group will be interviewed.
Timepoint [10] 406969 0
3 months after surgery

Eligibility
Key inclusion criteria
-Adults scheduled for elective, primary total hip or knee replacement surgery (THR or TKR) at the private hospital's two acute care sites
-Living independently in the community
-A Risk Assessment and Prediction Tool (RAPT) score of 6 to 9. This score range (6 to 9) predicts home discharge with additional intervention (e.g., rehabilitation-at-home).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients admitted via the emergency department indicating a non-elective procedure will 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)
The randomisation sequence will be given to a central administering site with no role in recruitment or assessment. A research assistant will allocate coded groups to control or intervention by contacting the holder of the allocation schedule at the central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study biostatistician (blind to group allocation) will generate the randomisation sequence using stratified block randomisation with variable block sizes of (2, 4 and 6) with groups coded as “A” and “B”. To ensure equal groups for factors that may influence discharge destination we will stratify by patient’s surgeon and surgery type (THR or TKR).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We aim to recruit and randomise 598 participants (299 in each group allowing for 5% drop out). Assuming current level of non-inpatient rehabilitation uptake among eligible patients is around 50%, 284 participants per group provides 80% power to detect a 12% increase (in absolute value) in the primary outcome with two-sided a of 0.05.

The primary analysis will measure the effect of the intervention on all primary and secondary outcomes between intervention group and control groups.

A secondary observational analysis will compare all secondary outcomes between those who received non-inpatient rehabilitation (i.e., rehabilitation-at-home or outpatient physiotherapy) versus the group that received inpatient rehabilitation.

The economic evaluation will take the Australian private healthcare system perspective by including estimates of costs directly relating to the private hospital service and clinical care for the participants hip or knee replacement surgery over a 3-month post-surgery horizon. The services include acute care (inpatient and hospital-at-home), inpatient rehabilitation, rehabilitation-at-home, and outpatient rehabilitation/physiotherapy. The economic evaluation will also take the societal perspective by including public and private health care costs, and productivity losses derived from reduced ability to work or undertake usual activities. The cost of implementation will also be estimated to generate eligible patient lists and organise the mailing of the letter. All participant cost data will be measured in $AUD.

For the process evaluation, inductive thematic analysis will be used to analyse qualitative data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/04/2022
Actual
1/06/2022
Date of last participant enrolment
Anticipated
3/07/2023
Actual
Date of last data collection
Anticipated
1/02/2024
Actual
Sample size
Target
598
Accrual to date
67
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 21849 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [2] 21850 0
Cabrini Brighton - Brighton
Recruitment postcode(s) [1] 36912 0
3144 - Malvern
Recruitment postcode(s) [2] 36913 0
3186 - Brighton

Funding & Sponsors
Funding source category [1] 309100 0
Charities/Societies/Foundations
Name [1] 309100 0
HCF Research Foundation
Country [1] 309100 0
Australia
Primary sponsor type
Individual
Name
Jason Wallis
Address
Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology, Cabrini Health; Level 2/154 Wattletree Rd, Malvern, VIC 3144
Country
Australia
Secondary sponsor category [1] 312168 0
None
Name [1] 312168 0
N/A
Address [1] 312168 0
N/A
Country [1] 312168 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308966 0
Monash Health
Ethics committee address [1] 308966 0
Ethics committee country [1] 308966 0
Australia
Date submitted for ethics approval [1] 308966 0
20/10/2021
Approval date [1] 308966 0
25/02/2022
Ethics approval number [1] 308966 0
Monash Health Reference: RES-21-0000-682A

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

Contacts
Principal investigator
Name 112506 0
Dr Jason Wallis
Address 112506 0
Cabrini Health
181-183 Wattletree Rd
Malvern VIC 3144
Country 112506 0
Australia
Phone 112506 0
+61 03 9508 3516
Fax 112506 0
Email 112506 0
[email protected]
Contact person for public queries
Name 112507 0
Jason Wallis
Address 112507 0
Cabrini Health
181-183 Wattletree Rd
Malvern VIC 3144
Country 112507 0
Australia
Phone 112507 0
+61 03 9508 3516
Fax 112507 0
Email 112507 0
[email protected]
Contact person for scientific queries
Name 112508 0
Jason Wallis
Address 112508 0
Cabrini Health
181-183 Wattletree Rd
Malvern VIC 3144
Country 112508 0
Australia
Phone 112508 0
+61 03 9508 3516
Fax 112508 0
Email 112508 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
Individual participant data from this study may not available for sharing consistent with current ethical approvals.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15238Study protocol    The trial protocol is planned to be published



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.