Understanding usual care in randomised controlled trials of complex interventions: A multi-method approach

SAGE Palliative Medicine & Chronic Care

This episode features Emel Yorganci (Cicely Saunders Institute of Palliative Care, Policy & Rehabilitation, London, UK). Usual care provided to patients is rarely described in detail in randomised controlled trials (RCTs) of a complex intervention in palliative care. To interpret the effectiveness of interventions tested within RCTs, the care provided in the comparison arm must be described. Approaches including the use of open-ended questions and observations have been used in trials to understand care provided but lack convergent validity. Usual care provided in an RCT was characterised using a multi-method approach at different time points and from different professional perspectives. Similarities and variations in the care provided to patients within and across study sites and over time were identified refuting the assumption that all control participants received the same usual care. This paper provides a method for the classification of the usual care that should be embedded within RCTs of complex interventions. Assumptions made about the usual care delivered to patients during intervention development may not always remain valid at the testing stage. Characterising usual care ensures that interpretation of findings of the effectiveness of the tested intervention is more valid.To avoid incorrect interpretations of complex interventions in palliative care, usual care is best characterised using a multi-method approach embedded within the design of RCTs.