Assessing the impact of a digitally enabled Wound Model of Care on chronic and complex wounds (The ENABLE Study)

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.