Trial Review

Please note that the ANZCTR will be unattended on Monday 9th June due to an Australian public holiday.

Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000562471
Ethics application status
Approved
Date submitted
22/04/2025
Date registered
2/06/2025
Date last updated
2/06/2025
Date data sharing statement initially provided
2/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the impact of a digitally enabled Wound Model of Care on chronic and complex wounds (The ENABLE Study)
Scientific title
Assessing the impact of a digitally enabled Wound Model of Care on hospital admissions for patients presenting with chronic and complex wounds (The ENABLE Study)
Secondary ID [1] 313485 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ENABLE
Linked study record
Follow up study to ACTRN12621000344897

Health condition
Health condition(s) or problem(s) studied:
Chronic wounds 335897 0
Complex wounds 335898 0
Condition category
Condition code
Skin 332492 332492 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ENABLE model is an integrative model of wound care that acts as a bridge between the hospital, specialist services and community care. There are two key components to the ENABLE Model of Care: (1) Accessing the specialist wound service and (2) the clinician using Tissue Analytics (digital wound platform). It is optional for the patient to use Tissue Analytics.

The ENABLE model of care provides:
• A person-centred approach to a wound specialist multidisciplinary service – Wound Command Centres;
• Prompt access/response for the treating clinician or patient/carer enhanced by timely access to a specialist virtual wound service. Clinicians can access expert advice on wound care for their patients and patients can access expert wound care via both face-to-face and real time audio-visual communication;
• A purpose-designed digital app (TGA approved: ARTG ID 374066); eMR-integrated, HIPPA compliant with real-time wound imaging to aid decision making and secure messaging to encourage partnership in patient care;
• Multiple connections between GPs, patients and nurses to enhance shared care;
• Data systems that intricately link wound healing data with comprehensive medical records allowing for benchmarking progress, providing a standardised measure to assess treatment effectiveness and patient outcomes.
There is no set timeframe regarding how often patients are to be reviewed as wounds should be reviewed as often as necessitated per clinical judgement regarding the wound’s healing progression and the complexity of the wound. The wound may not necessarily be reviewed by the same treating clinician at each consult. Treatment options are determined by the wound type, severity, co-morbidities, availability of wound care products, as well as patient compliance/acceptability.

Specialist wound service: Patients and clinicians access the service immediately once the patient is enrolled into the study. The duration of telehealth/face-to-face wound consultations will depend on the complexity of the wound, its healing progression and the needs of the patient. They can range from 20 minutes to an hour. The wound service will be available to the participants until the wound is showing signs of healing and the patient/carer/clinician is comfortable to manage the wound on their own until it is healed (wound closure).

Tissue Analytics digital wound platform: Clinicians and participants will have their own separate access points and log-ins to the digital wound app. It is optional for patients to use the patient app. If they do use the app, they should use the app to capture the wound image when they are changing the wound dressing. The treating clinician, in their own clinician app, will set how often patients are to be reminded to use the app to capture their wound image and can communicate with the patient via the Notes section of the app and vice versa. The clinician can view the wound images, wound documentation, and communicate with patients via the clinician app.
There is no minimum duration/frequency of access for clinicians when using the clinician app. Frequency/duration is determined by how often a wound’s dressing is to be changed which is when the image is captured (either by themselves using the clinician app or by their patient using the patient app) in order to monitor wound healing progression. The digital wound platform will be available to patients until the wound is healed (wound closure). The digital wound platform will be available for clinicians for the duration of the trial period or until their final enrolled patient’s wound has healed, whichever is later. The digital wound platform has a dashboard to monitor how many wound images/evaluations are captured.

A two-phase implementation-effectiveness study will be conducted. This design evaluates effectiveness of the ENABLE model of care and implementation strategy simultaneously, with the benefit of enabling broader uptake into clinical policy and practice. To facilitate translation, we will employ the Consolidated Framework for Implementation Research (CFIR) to guide the implementation and evaluation of ENABLE. The CFIR is a comprehensive framework that synthesises 19 implementation science theories to outline constructs necessary for successful implementation of an intervention. These constructs relate to the intervention characteristics, outer setting, inner setting, characteristics of individuals, and implementation process. CFIR has been used extensively to inform and evaluate implementation of policy and practice interventions, including digital health interventions. Guided by the CFIR, we will use qualitative and quantitative methods to systematically understand the implementation contexts, uncover barriers and facilitators, and optimise implementation of this model of care.

Phase 1 (co-development of implementation strategies with partners, understanding standard care, and Control/standard care period of the trial [baseline data collection]; 5 months) involves standard care exposure (control) and baseline data collection. Commencement of each site will be staggered with one site commencing the trial per month.
The CFIR framework will be used to co-develop with our partners tailored site implementation strategies to facilitate local uptake of ENABLE.
We will conduct patient interviews and clinician focus groups/interviews to inform phase 2 and understand standard care practices. We will understand existing usual wound care, identify barriers and develop facilitation strategies to ensure implementation and sustainability of the model.
Co-development process informing Phase 2: The facilitation and implementation strategies that emerge from qualitative work with patients and staff will be reviewed by the Clinical Expert and Consumer Group at each site, consisting of executives, wound care practitioners, implementation practitioners, and patients, who will provide advice on operationalising the strategies for the local context. All decisions will be made by consensus.

There will be a one month transition period between Phase 1 and Phase 2 to establish and operationalise the intervention and provide education.

Phase 2 (Intervention period of the trial including data collection; 6 months) will commence one month after the end of the control period which will use the implementation strategies developed in Phase 1 to implement the intervention and evaluate the clinical and cost effectiveness of the implementation of ENABLE.
Intervention code [1] 330059 0
Treatment: Other
Comparator / control treatment
Usual care is defined as the below for the purposes of this study:
• Primary Care Facilities: Patients wait for their appointment to their practitioner, or, for those with mobility issues, for the practitioner to visit them.
• Community district nursing: Patients are seen within two weeks of discharge from hospital if a referral is made by practitioner to community nursing. A care plan is developed at each visit to monitor the wound. If the wound is complex or not healing, the community nurse will request a joint visit with a wound specialist nurse.
• Residential Aged Care Facilities (RACFs): These facilities have varying levels of access to wound services and management methods of wounds are varied.
• For both Outpatient and Acute settings: in the rural and regional areas of Australia, optimal wound care is impeded by limited access to specialist review and clinical skills.
Control group
Active

Outcomes
Primary outcome [1] 340024 0
Proportion of patients admitted to hospital (patient presents to acute services) with a chronic or complex wound (wound that has not healed within 30 days as defined by NSW Health Value-Based Health Care Wound Tranche 2 and Value-Based Health Care High Risk Foot Service Tranche 1) for a wound as a principal diagnosis (ICD-10/SNOMED). This is a composite primary outcome.
Timepoint [1] 340024 0
Participants will be followed up for 90 days from the date of enrollment into the trial
Secondary outcome [1] 446619 0
Percentage change in wound size surface area
Timepoint [1] 446619 0
Every wound evaluation until final wound consultation (where wound is deemed to be healed)
Secondary outcome [2] 446620 0
Length of hospital stay
Timepoint [2] 446620 0
Participants will be followed up for 90 days from the date of enrollment into the trial.
Secondary outcome [3] 446623 0
Cost-effectiveness of ENABLE versus standard service;
Timepoint [3] 446623 0
Participants will be followed up for 90 days from the date of enrollment into the trial.
Secondary outcome [4] 446624 0
Patients’ health-related quality of life using EQ-5D-5L
Timepoint [4] 446624 0
Data on patients’ health-related quality of life using the EQ-5D-5L instrument will be collected both before and after the intervention periods at: • Baseline (before commencement of wound treatment) • Final wound consultation (where wound is deemed to be healed)
Secondary outcome [5] 446625 0
Patients’ care experiences
Timepoint [5] 446625 0
End of control phase, which is 5 months, and end of intervention phase, 6 months post-implementation
Secondary outcome [6] 446626 0
Clinicians’ experiences of providing care
Timepoint [6] 446626 0
End of control phase, which is 5 months, and end of intervention phase, 6 months post-implementation
Secondary outcome [7] 446627 0
Implementation outcome: acceptability
Timepoint [7] 446627 0
End of intervention phase, 6 months post-implementation
Secondary outcome [8] 448036 0
Implementation outcome: appropriatenes
Timepoint [8] 448036 0
End of intervention phase, 6 months post-implementation
Secondary outcome [9] 448037 0
Implementation outcome: feasibility
Timepoint [9] 448037 0
End of intervention phase, 6 months post-implementation
Secondary outcome [10] 448038 0
Implementation outcome: sustainability
Timepoint [10] 448038 0
End of intervention phase, 6 months post-implementation
Secondary outcome [11] 448039 0
Implementation outcome: fidelity
Timepoint [11] 448039 0
End of intervention phase, 6 months post-implementation

Eligibility
Key inclusion criteria
Patient inclusion criteria:
• Greater than or equal to 18 years with a chronic or complex wound (wound that has not healed within 30 days as defined by NSW Health Value-Based Health Care Wound Tranche 2 and Value-Based Health Care High Risk Foot Service Tranche 1)
AND
• In: primary care (GP practices), or community (community nursing), or residential aged care, or acute in-patient care or outpatient care.

Staff inclusion criteria:
• Clinician (doctors, nurses, podiatrists, occupational therapists) from one of our sites
AND
• Clinician who reviews, consults, and manages chronic wounds.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient Exclusion Criteria: Patients with superficial fast healing wounds such as abrasions, blisters, or superficial lacerations.
Clinician Exclusion Criteria: Nil

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation (by site size)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
We will use a sequential, multi-centre, incomplete, stepped-wedge, cluster randomised trial design (SWCRT). The SWCRT design was chosen over a traditional randomised controlled design as the SWCRT provides opportunity for each site (cluster) to be exposed to the intervention, while avoiding the practical challenges of rolling out the intervention to many sites simultaneously; and to adjust for possible seasonal effects. The SWCRT design is superior to a traditional randomised controlled design due to the inability of the latter design to minimise contamination between groups if randomising at patient level, noting randomisation at patient level is not feasible for this project.
The SWCRT provides opportunity for each research site (the ICU) or cluster to be exposed to the intervention. The incomplete design with staggered entry and exit points is used to facilitate a staggered trial commencement and minimise data burden, but without compromising statistical power of the trial.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
31/08/2026
Actual
Date of last data collection
Anticipated
29/11/2026
Actual
Sample size
Target
750
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT

Funding & Sponsors
Funding source category [1] 317925 0
Government body
Name [1] 317925 0
NHMRC Partnership Project Grant
Country [1] 317925 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 320270 0
None
Name [1] 320270 0
Address [1] 320270 0
Country [1] 320270 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316610 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 316610 0
Ethics committee country [1] 316610 0
Australia
Date submitted for ethics approval [1] 316610 0
28/10/2024
Approval date [1] 316610 0
21/03/2025
Ethics approval number [1] 316610 0

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

Contacts
Principal investigator
Name 138410 0
Prof Michelle Barakat-Johnson
Address 138410 0
King George V Building, 117 Missenden Rd, Sydney Local Health District, Camperdown 2050, New South Wales
Country 138410 0
Australia
Phone 138410 0
+61 425 248 946
Fax 138410 0
Email 138410 0
[email protected]
Contact person for public queries
Name 138411 0
Michelle Lai
Address 138411 0
King George V Building, 117 Missenden Rd, Sydney Local Health District, Camperdown 2050, New South Wales
Country 138411 0
Australia
Phone 138411 0
+61 436 858 705
Fax 138411 0
Email 138411 0
[email protected]
Contact person for scientific queries
Name 138412 0
Michelle Barakat-Johnson
Address 138412 0
King George V Building, 117 Missenden Rd, Sydney Local Health District, Camperdown 2050, New South Wales
Country 138412 0
Australia
Phone 138412 0
+61 425 248 946
Fax 138412 0
Email 138412 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.