Randomised controlled trials as part of clinical care: A seven-step routinisation framework proposal

Evidence translation in wound care relies on the need for evidence generation. Clinical practice may generate evidence only if evidence-generating research projects, such as randomised controlled trials (RCTs), became routinised in clinical settings. The aim of this study was to identify optimal trial-related practices to routinise trial-related activities in Melbourne-located wound clinics as reported by clinicians and researchers. We conducted a secondary analysis of the available data on how to routinise RCTs in clinical care, with a focus on enablers and suggestions provided by the participants during face-to-face and telephone interviews. Data were obtained from a qualitative observational study nested within a randomised, double-blinded, placebo-controlled trial on clinical effectiveness of aspirin as an adjunct to compression therapy in healing chronic venous leg ulcers (ASPiVLU). We developed a seven-step Routinisation of Trials in Clinical Care Framework. These steps include: (1) pre-trial clinical site assessment, (2) optimising pre-recruitment arrangements, (3) developing and updating trial-related skills, (4) embedding RCT recruitment as part of routine clinical care, (5) promoting teamwork and trial-related collaboration, (6) addressing trial-related financial issues, and (7) communicating trial results to clinicians.