Implementing a primary care disease management concept for venous leg ulceration: Findings of a mixed-methods process evaluation in the Ulcus Cruris Care trial

Background Care analyses show that evidence-based measures such as compression or promotion of mobility are rarely implemented in treatment of Venous leg ulcers (VLU). The Ulcus Cruris Care project designed a disease management concept to support evidence-based VLU treatment in general practices via online training and three e-learning modules for practice teams, software-supported case management, involving non-physician assistants, and promoting patient activation and education. The intervention program was implemented in a multicenter randomized controlled trial. A mixed-methods process evaluation explored intervention fidelity and perceived effects to identify improvement potential. Methods The cross-sectional process evaluation design applied semi-structured guide-based qualitative telephone interviews and a study-specific survey to evaluate the implementation process of the program. Results N = 38 survey questionnaires were completed and n = 27 interviews were conducted (n = 10 general practitioners, n = 10 non-physician assistants, n = 7 patients). Findings indicate high intervention fidelity regarding completion of the online training (100%), the e-learning modules (between 61% and 48%), application of standard operating procedures (100%), patient education material (91%), and case management software (91%). Practice teams and patients positively perceived the role of non-physician assistants as case managers and their involvement in wound treatment and patient education. Overall, the program was perceived as effective in fostering a change in treatment routines towards the regular use of compression therapy as the most effective treatment measure, patient and practice team education, and wound healing. Discussion The intervention program was assumed to lead to more frequent use of compression therapy, faster healing and less use of medical resources. Participants in the process evaluation perceived the intervention program as contribution to a structured, evidence-based VLU treatment, a gain in relevant knowledge for practice teams and patients and more active patient and relative participation. The outcome analysis in the Ulcus Cruris Care trial strengthened these findings and suggested a potential benefit of the intervention. Conclusion Promotion of comprehensive VLU treatment and care in general practices, including a regular use of compression therapy and active patient participation as facilitated by this intervention program appears to be largely suitable for a VLU case management approach. Trial registration : The trial protocol was registered in the German Clinical Trials Register on August 30, 2021 (DRKS00026126).