A digitally enabled home-based wound care program using the PEDALs model: a mixed-methods study protocol.

Background: Chronic wounds impose a significant burden on patients and caregivers because of complications such as pain, infection, and repeated trips to and from hospitals. These challenges are compounded by prolonged healing times and substantial socioeconomic costs, particularly in aging populations and resource-limited settings. The Digitally Enabled Home-Based Wound Care (DE-HBWC) program facilitates the organization of home visits by caregivers through electronic devices and internet platforms, enabling patients to easily receive medication changes and treatments, thus allowing patients to continue to reside in familiar surroundings while enjoying the same treatment as they would in a hospital. The construction of DE-HBWC programs for chronic wound patients in China is hampered by a lack of scientific theoretical guidance and high-quality research. The PEDALs (Problem, Evidence, Determinants, Actions, Long-term, Scales) model, a theoretical framework used in implementation research, as a rational framework for the DE-HBWC program in this study. Unlike conventional approaches, the PEDALs model emphasizes iterative adaptation and long-term scalability, ensuring alignment with real-world clinical needs and technological advancements. Methods: We designed a combined quantitative and qualitative study consisting of five phases and one monitoring step, following the PEDALs model. In Phase I, the clinical problem was defined as wound management challenges in patients with chronic wounds. In Phase II, a literature review and evidence-based practice were undertaken to address the research questions. In Phase III, in-depth interviews will be conducted to identify barriers and facilitators to the implementation of the DE-HBWC program in chronic wound patients. In Phase IV, the DE-HBWC intervention protocol will be developed and followed by a randomized controlled trial of the DE-HBWC intervention program. In Phase V, a DE-HBWC implementation plan that is sustainable over the long term will be developed to promote its use. Monitoring of the implementation of interventions in phases III to V will be conducted. Discussion: This study evaluated the impact of the DE-HBWC program on wound healing and quality of life in chronic wound patients and to assess its economic benefits. The findings are expected to help resolve challenges faced by patients with chronic wounds attending hospitals for wound care. Trial registration: Prospectively registered at the Chinese Clinical Trials Registry on 24.12.2023, ChiCTR2300079030.