Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001238561
Ethics application status
Approved
Date submitted
24/09/2024
Date registered
9/10/2024
Date last updated
9/10/2024
Date data sharing statement initially provided
9/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of an education session prior to elective hip or knee replacement surgery in hospital length of stay at St John of God Berwick Hospital
Scientific title
Impact of preoperative education Session on hospital length of stay in elective hip and knee replacement surgery
Secondary ID [1] 313089 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hip replacement 335260 0
knee replacement 335261 0
Condition category
Condition code
Musculoskeletal 331832 331832 0 0
Osteoarthritis
Public Health 331905 331905 0 0
Health service research
Surgery 331906 331906 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients scheduled for elective hip or knee replacement at SJG Berwick Hospital between September 2024 and March 2025 will be invited to attend a preoperative education session. They will receive an invitation via telephone and a copy of the Patient Information Statement and consent form. This education session represents a new initiative at SJG Berwick Hospital and will be conducted biweekly. Participants will only attend one education session prior to their surgery. The mode of delivery will be in a group setting up to 10 participants per session.

Participants who wish to be involved in the study will need to complete a consent form prior to attending the education session. The session, lasting 60 minutes, will be led by a physiotherapist or an occupational therapist and will utilize Microsoft PowerPoint slides. Topics covered will include an overview of hip/knee replacement, expectations post-surgery, the roles of physiotherapy and occupational therapy, hospital discharge planning, and necessary equipment for discharge. Following the session, participants will have the opportunity to ask questions and will be provided with an exercise sheet to complete weekly until their surgery date. It is noted that as most patients have already participated in an exercise program with physiotherapists external to SJG Berwick Hospital, the exercise component of this intervention will not be evaluated in the study.
Intervention code [1] 329589 0
Treatment: Other
Comparator / control treatment
Control Group
The control group will include patients who underwent elective hip or knee replacement at SJG Berwick Hospital between January 2024 and June 2024. These patients did not participate in a preoperative education session prior to their surgery at St John of God Berwick Hospital.
Control group
Historical

Outcomes
Primary outcome [1] 339453 0
Hospital Length of Stay
Timepoint [1] 339453 0
surgery date and discharge date
Secondary outcome [1] 440038 0
transitional referral rate to inpatient rehabilitation
Timepoint [1] 440038 0
at the conclusion of the study
Secondary outcome [2] 440303 0
transitional referral rate to outpatient rehabilitation
Timepoint [2] 440303 0
at the conclusion of the study
Secondary outcome [3] 440304 0
transitional rate to rehabilitation in the home
Timepoint [3] 440304 0
at the conclusion of the study

Eligibility
Key inclusion criteria
Patients who will have elective hip or knee replacement done at SJG Berwick Hospital between September 2024 and March 2025 will be eligible to participate in this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients are excluded if they are not booked an elective hip or knee replacement at SJG Berwick Hospital.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/10/2024
Actual
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317480 0
Hospital
Name [1] 317480 0
St John of God Berwick Hospital
Country [1] 317480 0
Australia
Primary sponsor type
Hospital
Name
St John of God Berwick Hospital
Address
Country
Australia
Secondary sponsor category [1] 319772 0
None
Name [1] 319772 0
Address [1] 319772 0
Country [1] 319772 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316194 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [1] 316194 0
Ethics committee country [1] 316194 0
Australia
Date submitted for ethics approval [1] 316194 0
03/09/2024
Approval date [1] 316194 0
24/09/2024
Ethics approval number [1] 316194 0
2223

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

Contacts
Principal investigator
Name 137094 0
Ms Angel Ching
Address 137094 0
St John of God Berwick Hospital, 75 Kangan Drive, Berwick, VIC 3806
Country 137094 0
Australia
Phone 137094 0
+61 387845484
Fax 137094 0
Email 137094 0
[email protected]
Contact person for public queries
Name 137095 0
Angel Ching
Address 137095 0
St John of God Berwick Hospital, 75 Kangan Drive, Berwick, VIC 3806
Country 137095 0
Australia
Phone 137095 0
+61 387845484
Fax 137095 0
Email 137095 0
[email protected]
Contact person for scientific queries
Name 137096 0
Angel Ching
Address 137096 0
St John of God Berwick Hospital, 75 Kangan Drive, Berwick, VIC 3806
Country 137096 0
Australia
Phone 137096 0
+61 387845484
Fax 137096 0
Email 137096 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24229Ethical approval    388509-(Uploaded-02-10-2024-08-25-46)-Ethics Approval.pdf



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.