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Trial registered on ANZCTR


Registration number
ACTRN12625000074493
Ethics application status
Approved
Date submitted
18/12/2024
Date registered
23/01/2025
Date last updated
23/01/2025
Date data sharing statement initially provided
23/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study testing virtual care for patients with rib fractures at home
Scientific title
A pilot study investigating the feasibility and safety of a virtual care model for out-of-hospital management of adult patients with traumatic rib fractures
Secondary ID [1] 313570 0
Nil known
Universal Trial Number (UTN)
Trial acronym
vRib Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rib fracture 336088 0
Condition category
Condition code
Emergency medicine 332641 332641 0 0
Other emergency care
Surgery 332646 332646 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible patients with traumatic rib fractures will be provided with a study pack containing:
- Written information on the vRib model of care
- Medications
- Tapentadol 50 mg oral tablet, Oxycodone 5mg oral tablet and/or Buprenorphine 200 mcg sublingual tablet
- Paracetamol 500 mg oral tablet
- Meloxicam or celecoxib oral tablets
- Wearable devices: pulse oximeter for measuring heart rate and oxygen saturation
- Smartphone, if patient unable to use their own mobile device

Specific medications provided will be tailored to individual patient needs and vary depending on factors such as patient allergies and age.

Patients will subsequently be discharged from the hospital. Upon arriving home, a member of the virtual hospital team will contact them and ensure the devices and mobile app are connected and functioning. Patients are also provided a phone number that they could use to contact the virtual hospital clinical team 24 hours per day, 7 days per week if required.

Patients receive video consultations twice a day by virtual hospital nursing staff, who will perform a comprehensive assessment, including assessment of pain scores and medication use. This is akin to standard care that patients receive while in hospital. Patients will also have a video consultation with a virtual hospital doctor and physiotherapist on the first day and on subsequent days if required. All consultations typically last up to 30 minutes, unless clinical necessity dictates otherwise. Patients will be discharged from the vRib model of care to their regular general practitioner once they meet pre-defined criteria. All patients will be followed up in the virtual hospital trauma clinic at day 30.
Intervention code [1] 330161 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340144 0
Recruitment time: time taken to recruit the sample size (feasibility measure)
Timepoint [1] 340144 0
End of study period
Primary outcome [2] 340281 0
Reach: proportion of eligible patients who received the intervention (feasibility measure)
Timepoint [2] 340281 0
End of study period
Primary outcome [3] 340282 0
Dropout rate: proportion of patients who received the intervention who then decided to exit the intervention in the absence of any clinical indication (feasibility measure)
Timepoint [3] 340282 0
End of study period
Secondary outcome [1] 443584 0
Treatment failure rate: proportion of patients who received the intervention who required hospital admission due to failure of out-of-hospital management (feasibility measure, additional primary outcome)
Timepoint [1] 443584 0
End of study period
Secondary outcome [2] 443586 0
Adverse respiratory event (safety measure, additional primary outcome), a composite outcome comprising: - Dyspnoea (new or worsening) - Empyema - Haemothorax (new or worsening) - Hypoxia (new or worsening) - Lung infection - Pleural effusion (new or worsening) - Pneumothorax (new or worsening) - Respiratory failure
Timepoint [2] 443586 0
Day 7 and Day 30 after intervention commencement
Secondary outcome [3] 443590 0
Pain: time-weighted sum of the pain intensity difference compared to baseline, with pain intensity measured on a numeric pain rating scale (0 to 10)
Timepoint [3] 443590 0
Day 1, Day 3 and Day 7 after intervention commencement
Secondary outcome [4] 443591 0
Daily utilisation of opioid medications, quantified in terms of oral morphine equivalent dose
Timepoint [4] 443591 0
Daily for the first 7 days after intervention commencement
Secondary outcome [5] 443594 0
Total (cumulative) utilisation of opioid medications, quantified in terms of oral morphine equivalent dose
Timepoint [5] 443594 0
Day 1, Day 3 and Day 7 after intervention commencement
Secondary outcome [6] 443595 0
Physiotherapy access (health care utilisation)
Timepoint [6] 443595 0
Day 3 after intervention commencement
Secondary outcome [7] 443596 0
Length of stay at virtual hospital (health care utilisation)
Timepoint [7] 443596 0
End of intervention
Secondary outcome [8] 443597 0
Overall length of stay, inclusive of traditional hospital admission (health care utilisation)
Timepoint [8] 443597 0
End of intervention
Secondary outcome [9] 443598 0
Hospital readmission (health care utilisation)
Timepoint [9] 443598 0
Day 30 after intervention commencement
Secondary outcome [10] 443599 0
Overall complications, a composite outcome comprising: - Pressure injury - Falls resulting in fracture or intracranial injury - Healthcare-associated infection (urinary tract infection, surgical site infection, pneumonia, blood stream infection, infections or inflammatory complications associated with peripheral/central venous catheters, multi-resistant organism, infection associated with prosthetics/implantable devices, gastrointestinal infections, other high impact infections such as sepsis) - Surgical complications requiring unplanned return to theatre - Unplanned intensive care unit admission - Respiratory complications (respiratory failure including acute respiratory distress syndrome, aspiration pneumonia, pulmonary oedema) - Venous thromboembolism (pulmonary embolism, deep vein thrombosis) - Acute renal failure requiring haemodialysis or continuous veno-venous haemodialysis - Gastrointestinal bleeding - Medication complications (drug-related respiratory complications/depression, haemorrhagic disorder due to circulating anticoagulants, movement disorders due to psychotropic medication, serious alteration to conscious state due to psychotropic medication) - Delirium - Urinary or faecal incontinence - Endocrine complications (malnutrition, hypoglycaemia) - Cardiac complications (heart failure and pulmonary oedema, arrhythmias, cardiac arrest, acute coronary syndrome, infective endocarditis)
Timepoint [10] 443599 0
Day 7 and Day 30 after intervention commencement
Secondary outcome [11] 443600 0
Death
Timepoint [11] 443600 0
Day 30 after intervention commencement
Secondary outcome [12] 443601 0
Self-reported health outcome
Timepoint [12] 443601 0
Day 30 and Day 60 after intervention commencement
Secondary outcome [13] 443602 0
Return to work
Timepoint [13] 443602 0
Day 30 and Day 60 after intervention commencement
Secondary outcome [14] 443604 0
Patient-reported experience measure
Timepoint [14] 443604 0
2 weeks post-discharge

Eligibility
Key inclusion criteria
- Patient is 18 years of age or older
- Patient has one or more radiologically-confirmed traumatic rib fractures
- Patient has been admitted or referred to the hospital Trauma Service
- Patient reports moderate to severe pain (numeric pain rating scale score greater than or equal to 4) during the previous 24 hours
- Patient has been identified by the Trauma Service, Admitting Medical Officer (or delegate), and virtual hospital Consultant as being suitable for ongoing treatment in a community setting with virtual support
- All vital signs within standard parameters; exceptions on case-by-case basis with discussion with the on-call virtual hospital Consultant
- Pain adequately managed with oral analgesia; must be more than 12 hours following administration of a nerve block containing long-acting local anaesthetic or 6 hours following administration of parenteral analgesia
- Patient can maintain essential activities of daily living (ADL) or has carer assistance in place for maintenance of ADLs; patients with dementia could be eligible provided they have a well-supported home environment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient or their substitute decision-maker does not provide consent
- Patient has an intercostal catheter (ICC) in-situ or removed < 12 h earlier
- Patient has ongoing acute care needs for other concurrent acute medical conditions or injuries that require inpatient care
- Clinical concern for sepsis
- Patient requires ongoing parenteral opioid or regional block support for analgesia
- Patient has been admitted to hospital for 7 days or more
- Patient lives outside the virtual hospital's catchment area
- Patient unable/unwilling to use video-conferencing or wearable technology

Study design
Purpose of the study
Treatment
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2025
Actual
Date of last participant enrolment
Anticipated
31/07/2025
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27416 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 43529 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 318033 0
Government body
Name [1] 318033 0
Sydney Local Health District
Country [1] 318033 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 320378 0
None
Name [1] 320378 0
Address [1] 320378 0
Country [1] 320378 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316690 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 316690 0
Ethics committee country [1] 316690 0
Australia
Date submitted for ethics approval [1] 316690 0
01/10/2024
Approval date [1] 316690 0
02/12/2024
Ethics approval number [1] 316690 0
2024/ETH02102

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

Contacts
Principal investigator
Name 138678 0
Dr Melanie Berry
Address 138678 0
RPA Virtual Hospital, Level 9, King George V Building, 83 Missenden Road, Camperdown NSW 2050
Country 138678 0
Australia
Phone 138678 0
+61460002931
Fax 138678 0
Email 138678 0
[email protected]
Contact person for public queries
Name 138679 0
Melanie Berry
Address 138679 0
RPA Virtual Hospital, Level 9, King George V Building, 83 Missenden Road, Camperdown NSW 2050
Country 138679 0
Australia
Phone 138679 0
+61460002931
Fax 138679 0
Email 138679 0
[email protected]
Contact person for scientific queries
Name 138680 0
Melanie Berry
Address 138680 0
RPA Virtual Hospital, Level 9, King George V Building, 83 Missenden Road, Camperdown NSW 2050
Country 138680 0
Australia
Phone 138680 0
+61460002931
Fax 138680 0
Email 138680 0
[email protected]

Data sharing statement
Will sharing of individual participant data from this study be considered?
No
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?

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.