Randomised controlled trials (RCTs) to evaluate complex healthcare interventions - a case study

In 2001 the UK National Health Service (NHS) issued its National Service Framework for the Elderly (NSF-E). This identified the elderly as a vulnerable group needing a high level of pharmaceutical intervention. As such, the NSF-E outlined plans to implement ‘medicines management’ and ‘pharmaceutical care’ within community-based clinical pharmacy on behalf of older people. In response a group of researchers from Pharmacy, General Practice and Health Services Research set about designing a project to evaluate community-based pharmaceutical care for the elderly which would be funded under the Medical Research Council’s (MRC) ‘primary care’ initiative. This article describes the application of the MRC’s framework for complex interventions to a large randomised trial of pharmaceutical care and discusses the stages through which the research passed, from ideas, through planning, to implementation and modification after piloting. The authors also highlight difficulties encountered, e.g., issues of patient confidentiality, and how these problems were resolved. This description is intended to be of value to other pharmacy practice researchers.