Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000934640
Ethics application status
Approved
Date submitted
25/07/2023
Date registered
29/08/2023
Date last updated
10/12/2023
Date data sharing statement initially provided
29/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
RECITAL: Evaluating a virtual clinic for people with simple fractures
Scientific title
Effects of virtual fractuRE Clinic care compared with In-person fracture clinic care on physical function in people with simple fractures: a non-inferiority randomised TriAL (RECITAL)
Secondary ID [1] 310297 0
None
Universal Trial Number (UTN)
U1111-1285-2379
Trial acronym
RECITAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute (<6weeks) simple fractures that can be managed conservatively, including non-displaced/minimally displaced limb fractures or injuries. 328245 0
Condition category
Condition code
Injuries and Accidents 325293 325293 0 0
Fractures
Musculoskeletal 327809 327809 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will receive care virtually.

Patients will be provided a follow-up appointment at the virtual fracture clinic within 5 days after their referral is received. Patients will be sent an email with the details of their appointment date/time, a Zoom link for the virtual consult, contact details of the clinic, and the respective fracture management fact sheet. The RPA Virtual Hospital's fact sheets explain the clinical condition, expectation of the recovery, early rehabilitation exercises, activity limitations, and clear information on care escalation. These fact sheets were adapted with permission from the Royal Melbourne Hospital, and were approved by the RPA Virtual Hospital's Consumer Group.

All patients will be offered a video-consult with a physiotherapist unless they choose to have their review via phone. During the virtual consult, the physiotherapist will conduct a subjective and objective assessment, discuss the x-ray findings and provide a management plan. Patients will be offered the opportunity to ask questions prior to ending the consultation. The anticipated duration of the consult sessions will be approximately 30 minutes. An email summary of the consultation, along with the follow-up appointment details will be sent to the patient. A Physitrack link for tailored exercise videos and instructions may also be included in this email. Patients will be offered a follow-up virtual appointment at 2- and 6-weeks post-fracture, or based on clinical need. Patients can contact the physiotherapist via phone or email during business hours if they have any concerns during their care period. Most patients will be discharged at 6-weeks post-fracture if they have no other concerns. We will monitor patient adherence by the number of consults attended, and the number of adhoc patient contacts via phone or email with the clinic.

The physiotherapist will organise an interpreter prior to the virtual consult if the patient requires assistance with language. Patients who identify as Aboriginal and/or Torres Strait Islander are also offered support from the Aboriginal Cultural Support Team as per current process.
Intervention code [1] 324891 0
Treatment: Other
Comparator / control treatment
Participants in the control group will receive care at the in-person fracture clinic.

Patients will be provided a follow-up appointment at the in-person fracture clinic 7 to 10 days after their referral is received, based on the next clinic of the on-call orthopaedic doctor, as per usual practice. Clinical management and subsequent follow-ups of the control group is determined by the orthopaedic doctors at the in-person fracture clinic. Clinical management can include a physical assessment by a doctor, radiology scan, advice and exercises. A physiotherapist may be involved in the patient’s care. Patients in the control group may receive written instructions about their recovery and exercises as per current processes. The anticipated duration of the consult sessions will be approximately 20 minutes. Current practice suggests that patients may be attend the in-person fracture clinic once or twice within 6-weeks post-fracture. We will monitor patient adherence by the number of consults attended.
Control group
Active

Outcomes
Primary outcome [1] 335422 0
Physical function outcomes will be assessed using the Patient-Specific Functional Scale (PSFS)
Timepoint [1] 335422 0
Baseline, 6 and 12 weeks (primary timepoint) post-randomisation
Secondary outcome [1] 424471 0
Health-related quality of life will be assessed using the EuroQol 5D 5L (EQ-5D-5L)
Timepoint [1] 424471 0
Baseline and 12 weeks post-randomisation
Secondary outcome [2] 424472 0
Pain will be measured using the 0-10 Numerical Rating Scale (NRS)
Timepoint [2] 424472 0
Baseline, 6 and 12 weeks post-randomisation
Secondary outcome [3] 424473 0
Patient-reported experience will be measured using the Generic Short Patient Experiences Questionnaire (GS-PEQ)
Timepoint [3] 424473 0
6 weeks post-randomisation
Secondary outcome [4] 424474 0
Cost borne by the healthcare provider will be measured through the electronic medical records, Sydney Local Health District Targeted Activity and Reporting System (STARS App) Dashboard, and the hospital’s performance, data and finance departments to obtain the healthcare appointment duration, healthcare provider’s hourly rate, any health services utilisation and corresponding cost (including but not limited to outpatient, inpatient, emergency department, pharmacy, radiology, pathology and primary care), any infrastructure setup and maintenance cost, managerial and administrative overhead.
Timepoint [4] 424474 0
12 weeks post-randomisation
Secondary outcome [5] 424475 0
Healthcare utilisation will be measured using a patient survey designed specifically for this study to assess the number of other healthcare appointments for management of their injury. The research team will also ascertain if the patients utilised any other healthcare services through the patient’s electronic medical records.
Timepoint [5] 424475 0
12 weeks post-randomisation
Secondary outcome [6] 424476 0
Medication use will be measured using a patient survey designed specifically for this study to assess the name and dose of prescription or over the counter medication for their injury.
Timepoint [6] 424476 0
6 weeks post-randomisation
Secondary outcome [7] 425714 0
Adverse Events will be measured using a patient survey designed specifically for this study, safety reports from the electronic medical records (eMR), NSW Health Incident Management System (ims+).
Timepoint [7] 425714 0
6 and 12 weeks post-randomisation
Secondary outcome [8] 425715 0
Serious Adverse Events will be measured using a patient survey designed specifically for this study, safety reports from the electronic medical records (eMR), NSW Health Incident Management System (ims+).
Timepoint [8] 425715 0
6 and 12 weeks post-randomisation
Secondary outcome [9] 425716 0
Emergency Department re-presentations will be measured through the electronic medical records.
Timepoint [9] 425716 0
12 weeks post-randomisation
Secondary outcome [10] 425717 0
Number of patients requiring surgery will be measured through the electronic medical records.
Timepoint [10] 425717 0
12 weeks post-randomisation
Secondary outcome [11] 425855 0
Cost borne by patients will be measured through the patient survey designed specifically for this study.
Timepoint [11] 425855 0
12 weeks post-randomisation

Eligibility
Key inclusion criteria
a. Acute (<6 weeks) simple fractures such as base of fifth metatarsal (foot), Weber A (ankle), Mason I radial head (elbow) or clavicle (collar bone).
b. Aged 18 years or older,
c. The condition can be managed using removable orthoses including tapes and bandages,
d. Conditions in point (a) that are deemed appropriate for virtual management by the orthopaedic doctor,
e. Patient has access to a phone and an active telephone number,
f. Patient is within New South Wales at the time of consult,
g. Patient is willing to participate and comply with the study requirements,
h. A radiology scan showing or reporting the injury mentioned in point (a).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Patients with complex or significantly displaced fracture, including pathological, open, unstable or spinal fractures,
b. Patients requiring a cast or surgical management,
c. Neurovascular concerns,
d. Conditions not managed by RPA Hospital Orthopaedics Department,
e. Patients who are unable to attend the in-person fracture clinic within the recommended follow-up time,
f. Patients who opt-out of this study.

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)
Randomisation will be computer-generated using REDCap’s randomisation model. Only the biostatistician will be aware of the allocation to ensure concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A biostatistician not involved in this study will set up the allocation schedule with random blocks of 4, 6, 8 and 10 to ensure equal numbers in both groups and upload it into REDCap.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
312 participants will provide 90% power to detect a non-inferiority margin of 0.7 points on the 11-point PSFS with a 10% loss to follow-up, a standard deviation of 2.0, and a correlation score between baseline and final scores of 0.5 at 12-weeks. A negative between-group difference of 0.7 points will indicate that the virtual fracture clinic is non-inferior to the in-person fracture clinic, with the following assumptions:
a. 2-tailed alpha, a = 0.05
b. Power, 1-ß = 0.9
c. Ratio of case to control, k = 1
d. Allowable difference, d=µT-µC = 0
e. Expected population standard deviation, SD = 2.0
f. Margin of clinically meaningful difference, d = 0.7
g. Drop out rate = 10%

Descriptive statistics will be used for patient demographics and clinical characteristics. Categorical variables will be described with frequencies (%), and continuous variables will be described with means and standard deviations. The PSFS score at 12-weeks post-randomisation is the primary outcome in this study and we have defined a non-inferiority margin of -0.7 points, which is the maximum difference we are prepared to tolerate and still consider virtual care not to be clinically inferior to in-person care. The null hypothesis is therefore that a difference of greater than 0.7 points on the PSFS exists in favour of in-person care. This will be assessed by creating a 95% confidence interval (95% CI), which should be entirely above the non-inferiority margin for the intervention to be declared non-inferior.

The PSFS score will be compared between treatment groups as the dependent variable in a generalised linear regression model for the primary analysis adjusting for baseline PSFS variables. The treatment difference will be based on the estimate of adjusted means and 95% confidence intervals. Secondary clinical outcomes will be analysed using logistic regression for binary outcomes and linear regression for continuous outcomes.

Data will be analysed using STATA version 14 statistical software (StataCorp, College Station, TX) or R version 4.2.1 (R Foundation for Statistical Computing, Vienna, Austria).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/09/2023
Actual
20/11/2023
Date of last participant enrolment
Anticipated
1/09/2025
Actual
Date of last data collection
Anticipated
24/11/2025
Actual
Sample size
Target
312
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25230 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 40900 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 312690 0
Government body
Name [1] 312690 0
NHMRC 2022 MRFF Clinician Researchers - Nurses Midwives and Allied Health
Country [1] 312690 0
Australia
Funding source category [2] 314335 0
Other Collaborative groups
Name [2] 314335 0
Sydney Research – Clinician Researcher Scholarship
Country [2] 314335 0
Australia
Primary sponsor type
Hospital
Name
RPA Virtual Hospital
Address
Level 9, King George V Building
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 316283 0
None
Name [1] 316283 0
N/A
Address [1] 316283 0
N/A
Country [1] 316283 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311992 0
Sydney Local Health District Human Research Ethics Committee (HREC) - RPAH
Ethics committee address [1] 311992 0
Ethics committee country [1] 311992 0
Australia
Date submitted for ethics approval [1] 311992 0
30/05/2023
Approval date [1] 311992 0
14/07/2023
Ethics approval number [1] 311992 0
2023/ETH01038

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

Contacts
Principal investigator
Name 123094 0
Dr Adrian Traeger
Address 123094 0
The University of Sydney, Gadigal Country
Faculty of Medicine and Health, School of Public Health, Institute for Musculoskeletal Health
Level 10N, King George V Building
Missenden Road
Camperdown NSW 2050
Country 123094 0
Australia
Phone 123094 0
+61 416 122 784
Fax 123094 0
Email 123094 0
adrian.traeger@sydney.edu.au
Contact person for public queries
Name 123095 0
Min Jiat Teng
Address 123095 0
RPA Virtual Hospital
Level 9, King George V Building
Missenden Road
Camperdown NSW 2050
Country 123095 0
Australia
Phone 123095 0
+61 421 398 669
Fax 123095 0
Email 123095 0
min.teng@health.nsw.gov.au
Contact person for scientific queries
Name 123096 0
Min Jiat Teng
Address 123096 0
RPA Virtual Hospital
Level 9, King George V Building
Missenden Road
Camperdown NSW 2050
Country 123096 0
Australia
Phone 123096 0
+61 421 398 669
Fax 123096 0
Email 123096 0
min.teng@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified individual participant data collected during the trial
When will data be available (start and end dates)?
From the time of publication until the 15 years after
Available to whom?
To any researcher working in the same or similar field
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Ethics approval will be required prior to accessing any of these data. Interested parties will need to request the data from RPA Virtual Hospital's General Manager and the Sydney Local Health District Human Research Ethics Committee (HREC) - RPAH. The RPA Virtual Hospital's General Manager can be contacted via the research office on SLHD-RPAVirtualHospitalResearch@health.nsw.gov.au or +61 428 115 948.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19798Study protocol  min.teng@health.nsw.gov.au Study protocol will be made available upon reasona... [More Details]



Results publications and other study-related documents

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