Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000344897
Ethics application status
Approved
Date submitted
12/01/2021
Date registered
25/03/2021
Date last updated
25/03/2021
Date data sharing statement initially provided
25/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Addressing the hidden burden of wound care amid the COVID-19 pandemic: A Virtual Wound Care Command Centre.
Scientific title
Addressing the hidden burden of wound care amid the COVID-19 pandemic: Evaluation of the feasibility and acceptability of a Virtual Wound Model of Care using a digital application for timely access and monitoring.
Secondary ID [1] 303546 0
None
Universal Trial Number (UTN)
U1111-1263-3847
Trial acronym
VATICAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Wounds 320176 0
Condition category
Condition code
Skin 318121 318121 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a Virtual Wound Model of care using a digital application that supports a Virtual Wound Care Command Centre (VATICAN) consisting of a telemedicine system with remote consultation where the clinician responsible assesses, manages, prescribes and documents wound care treatment as a remote specialist. Each consult is conducted as a 30 min session per patient, every-week or more frequently if the wound care plan needs to be changed or if the wound is not improving. The patient, carer, or community clinician will be empowered to implement the prescribed wound treatment. Patients are followed through from time of enrolment until the wound is completely healed or to the end of the study period. The intervention will be tested over a period of 6 months. The VATICAN uses a digital application (app), Tissue AnalyticsTM (TA), for clinicians to measure, analyse and treat wounds. By capturing an image of the wound, the digital app analyses and visualises wound dimensions and perimeters, surface area and tissue composition. The digital app requires a smartphone with integrated camera. It has two interfaces, one for the clinician and one for the patient. The patient-facing app is used by patients to manage their wound or when they require regular monitoring by clinicians. Patients are trained on the use of the app at the time of enrolment. Patients are instructed to take an image of their wound every 2 to 7 days or as the change in dressing requires.
Intervention code [1] 319393 0
Treatment: Other
Intervention code [2] 319830 0
Treatment: Devices
Comparator / control treatment
Hospitals have varying levels of access to wound management services on discharge. Management methods of chronic wounds are varied and do not align with do not always align with best practice standards. Outpatient Clinics such as Dermatology and Vascular: Patients either have to wait for their appointment to their treating practitioner or the treating practitioner to make a trip to see the patient for those with mobility difficulties. Both of which, result in delayed or long waiting time to get advice from the wound care specialist. Community nursing: Patients are seen within 2 weeks. On admission a wound assessment based on nursing experience is conducted with findings documented in the electronic medical record, but no photos are taken. A treatment plan is developed and at each visit to monitor the status of the wound. If the wound is complex or not healing, the community nurse will request a joint visit with a wound specialist nurse. There are no referral pathways for this yet.
The impact of the intervention on patient visits to hospital, time to consultation and patient perception of their wound care management will be compared to pre-implementation data. These data are collected in the form of a patient-survey before the intervention and then at the end of their treatment or at the end of the study period. In addition, historic data spanning the last 3 years will be collected using the medical records database for each site.
Control group
Historical

Outcomes
Primary outcome [1] 326124 0
Feasibility and acceptability of Tissue AnalyticsTM (TA) application by clinician measured using a 6-item 5-point Likert scale survey specifically designed for this study group.
Timepoint [1] 326124 0
Measured at the end of the study period.
Primary outcome [2] 326125 0
Feasibility and acceptability of TA application by patient measured using a 14 question 5-point Likert scale survey designed to capture equipment/technical issues, communication and rapport, clinical assessment and overall program evaluation.
Timepoint [2] 326125 0
Measured at the end of the study period
Secondary outcome [1] 390204 0
Time to consultation defined as the time taken between first noticing wound to the time of review and triage of the wound, collected using data from TA app.
Timepoint [1] 390204 0
Cumulative data collected throughout the study will be assessed at the end of the study period
Secondary outcome [2] 392257 0
Impact on patient travel-related time, estimated by inputting residence and destination addresses into Google maps.
Timepoint [2] 392257 0
Cumulative data collected throughout the study will be assessed at the end of the study period
Secondary outcome [3] 392258 0
Change in wound size over time measured as percentage change wound surface area divided by the number of weeks, using data from TA app.
Timepoint [3] 392258 0
Baseline (start of enrolment) and then fortnightly until wound is healed or end of the study period, whichever occurs first.

Eligibility
Key inclusion criteria
Inclusion criteria for patients:
1. Patients 18 years of age and older who are discharged from health care with an unhealed wound(s) and:
(a) Have access to and can use a smartphone, OR
(b) Have a carer that has access to and can use a smartphone

Inclusion criteria for clinicians include:
1. Wound clinical nurse consultants, skin integrity nurse specialists, vascular surgeons and podiatrists that have a patient that requires wound care management
2. Have access to and can use a smartphone
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with a wound that requires specialised treatment, such as burns/scalds
2. Patients with a non-healing wound such as palliative, malignant or fungating tumours
3. Patients with wounds with a blind-ended track such as pilonidal sinus or wound sinus
4. Patients with a superficial fast-healing wound such as abrasions, blisters or superficial lacerations and do not require continual wound monitoring.
5. Patients that have cognitive impairment, as determined by the treating physician
6. Patients that do not have access to or cannot use a smartphone.

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
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Participants interviews will be transcribed and managed in NVivo 10 software (QSR International, Melbourne, Australia). Thematic analysis of transcripts will be performed to develop a meaningful understanding of the data.
Data from the brief surveys completed by patients and clinicians will be entered directly into the IBM SPSS database and then exported to the online database to check for data entry errors. These errors were then manually corrected in SPSS. Participant opinions will be measured by summing the scores on the individual Likert scale, which ranges between 6-36 for clinician survey (six items, rated on a five Libert-scale), and 0-56 for the patient survey (fourteen items, rated on a five Libert-scale).

The potential travel time by patients and the potential reduction in carbon foot print as a result of receiving virtual wound care with TA app will be estimated.The time was be estimated by using Google maps. Mean travel time will be calculated by using the minimum and the maximum travel time provided by Google map.

Timely access will be calculated

A reduction in wound size will be measured as an outcome by calculating the percentage change in wound size divided by the number of weeks since enrolment. Measurements will be performed weekly. The wound area measurement will be collected via the Tissue Analytics portal. The Tissue Analytics portal has a functionality to provide both individual and aggregated data that are inputted by clinicians while routinely using the mobile application.

The wound areas are measured by Artificial Intelligence as part of the built-in functionality of the Tissue Analytics. The data points which are available and to be extracted from the portal include (1) wound surface area measured from each wound image, (2) an area difference compared to the first wound area measured, (3) an area percentage change compared to the first wound area measured, (4) length, width and depth of wounds, (5) healing rate (the percentage change in wound size divided by the number of weeks since enrolment.)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/12/2020
Date of last participant enrolment
Anticipated
1/06/2021
Actual
Date of last data collection
Anticipated
1/07/2021
Actual
Sample size
Target
60
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18330 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 18331 0
Wagga Wagga Base Hospital - Wagga Wagga
Recruitment hospital [3] 18332 0
Westmead Hospital - Westmead
Recruitment hospital [4] 18333 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 32408 0
2050 - Camperdown
Recruitment postcode(s) [2] 32409 0
2650 - Wagga Wagga
Recruitment postcode(s) [3] 32410 0
2145 - Westmead
Recruitment postcode(s) [4] 32411 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 307493 0
Government body
Name [1] 307493 0
Medical Research Future Fund, Department of Health, Australian Government
Country [1] 307493 0
Australia
Primary sponsor type
Hospital
Name
Sydney Local Health District - Royal Prince Alfred Hospital (RPAH)
Address
Royal Prince Alfred Hospital
50 Missenden Road
Camperdown, NSW 2050
Country
Australia
Secondary sponsor category [1] 308194 0
None
Name [1] 308194 0
Address [1] 308194 0
Country [1] 308194 0
Other collaborator category [1] 281579 0
University
Name [1] 281579 0
University of Sydney
Address [1] 281579 0
The University of Sydney
City Rd
Camperdown, NSW 2006
Australia
Country [1] 281579 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307568 0
Sydney Local Health District HREC – RPAH
Ethics committee address [1] 307568 0
Ethics committee country [1] 307568 0
Australia
Date submitted for ethics approval [1] 307568 0
12/11/2020
Approval date [1] 307568 0
14/12/2020
Ethics approval number [1] 307568 0
X19-0307 & 2019/ETH12459

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

Contacts
Principal investigator
Name 107706 0
Dr Michelle Barakat-Johnson
Address 107706 0
C/- Royal Prince Alfred Hospital
Level 7 Patient Safety and Quality
50 Missenden Road
Camperdown, NSW 2050
Sydney Local Health District
Country 107706 0
Australia
Phone 107706 0
+61 434899098
Fax 107706 0
Email 107706 0
[email protected]
Contact person for public queries
Name 107707 0
Michelle Barakat-Johnson
Address 107707 0
C/- Royal Prince Alfred Hospital
Level 7 Patient Safety and Quality
50 Missenden Road
Camperdown, NSW 2050
Sydney Local Health District
Country 107707 0
Australia
Phone 107707 0
+61 434899098
Fax 107707 0
Email 107707 0
[email protected]
Contact person for scientific queries
Name 107708 0
Michelle Barakat-Johnson
Address 107708 0
C/- Royal Prince Alfred Hospital
Level 7 Patient Safety and Quality
50 Missenden Road
Camperdown, NSW 2050
Sydney Local Health District
Country 107708 0
Australia
Phone 107708 0
+61 434899098
Fax 107708 0
Email 107708 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
Although the data is de-identified, it is primarily qualitative. Surveys are anonymously conducted.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Accepted 21 Feb 2022 Article ID: IWJ13782 Articl... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe viability and acceptability of a Virtual Wound Care Command Centre in Australia.2022https://dx.doi.org/10.1111/iwj.13782
N.B. These documents automatically identified may not have been verified by the study sponsor.