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 become evidence-generating only if evidence generating research projects, such as randomized controlled trials, became routinized in clinical settings. The aim of this study was to identify optimal trial-related practices to routinize trial-related activities in Melbourne-located wound clinics as reported by clinicians and researchers. We conducted secondary analysis of the available data on how to routinize RCTs in clinical care, with a focus on enablers and suggestions provided by the participants during face-to-face and telephone interviews. Data was obtained from a qualitative observational study nested within a randomized 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 Routinization of Trials in Clinical Care Framework. These steps include: (a) pre-trial clinical site assessment; (b) optimizing pre-recruitment arrangements; (c) developing and updating trial-related skills; (d) embedding RCT recruitment as part of routine clinical care; (e) promoting teamwork and trial-related collaboration; (f) addressing trial-related financial issues; (g) communicating trial results to clinicians.