Implementing a digitally enabled wound model of care to improve chronic wound outcomes in seven health services in Australia: Study protocol for a multisite, hybrid type 2, two-phase effectiveness-implementation trial (the ENABLE study)

Introduction: Chronic wounds place a substantial clinical, psychosocial and economic burden on individuals, health systems and communities. Fragmented and uncoordinated wound care practices lead to inefficiencies and variations in practice, delayed access to specialists and poor patient outcomes. While digital and AI wound care technologies offer promising solutions, robust multisite effectiveness-implementation trials of these technologies in diverse real-world
healthcare contexts is limited. This multisite study aims to evaluate the implementation and effectiveness of a digital model of wound care across seven metro, regional and rural health services in Australia.

Methods and analysis: The ENABLE study is a hybrid type 2, two-phase effectiveness implementation trial of a digitally enabled model of wound care. Phase 1 is guided by the Consolidated Framework for Implementation Research and involves the co-development of tailored implementation strategies informed by patient and clinician interviews and focus groups to identify the barriers and facilitators to implementation across seven diverse sites, including primary care, community nursing, residential aged care and hospital inpatient and outpatient settings. In Phase 2, the clinical effectiveness of the model is evaluated using a stepped-wedge cluster randomised trial (SW-CRT) involving approximately 750 patients across seven clusters, along with a mixed-methods evaluation and an economic analysis. The primary outcome is the proportion of patients admitted to hospital with a chronic or complex wound diagnosis. Secondary outcomes include wound size reduction, length of hospital stay, health-related quality of life, patient and clinician experiences, implementation outcomes (acceptability, appropriateness, feasibility, adoption, sustainability and fidelity) and cost effectiveness.

Ethics and dissemination: Ethical approval was obtained from the Sydney Local Health District Human Research Ethics Committee (protocol version 7.0; protocol no.: X24-0360; ethics identifier: 2024/ETH02394; 10 February 2026). All participants will provide written informed consent prior to participation. The results will be disseminated through peer-reviewed publications, presentations to conferences and health governing agencies and stakeholder educational activities. Clinical results will be reported in line with the Consolidated Standards of Reporting Trials (SW-CRT extension), Standards for Reporting Implementation Studies and Consolidated Criteria for Reporting Qualitative Research, and economic evaluation will be reported in line with the Consolidated Health Economic Evaluation Reporting Standards.

Registration: Registered 2 June 2025 with the Australian New Zealand Clinical Trials Registry (ACTRN12625000562471).