An exploration of factors affecting the implementation of a randomized controlled trial of a transitional discharge model for people with a serious mental illness.

Information about the contexts in which trials are carried out helps to identify confounding influences on the application of a trial. Furthermore, the ways in which context and implementation of trials influence participation are particularly important for trials which utilize people as part of the intervention. This is particularly likely in the mental health and psychosocial fields. The researchers used mixed methods to identify quality issues encountered during the conduct of a trial, aiming to explore process and contextual factors encountered during its implementation in a mental health setting. Staff and peer volunteers who contributed to the intervention provided information on implementation via diaries and group meetings. Findings in this paper relate to staff feedback. By providing an insider view, researchers were able to highlight the importance of obtaining feedback on implementation. Findings relate to the context of the study, particularly organizational, practitioner and trial preparation issues and illustrate the importance of building quality assurance mechanisms into research plans, such as monitoring and feedback processes. The issue of 'people involvement' in trial delivery requires sensitive management and flexibility in both preparation and delivery.