When clinical trials of complex interventions fail to demonstrate intervention effectiveness, this may be attributable to poor implementation rather than an ineffective intervention. Implementation methods and strategies can support implementation of complex interventions within trials, but these are often under-researched and poorly reported. By improving their reporting, we can address weaknesses, reduce research waste and improve quality of clinical trials.
The aim of this PhD was to investigate methods used to measure implementation and strategies employed to optimise implementation of a complex intervention within the context of trials involving older people, and their potential to impact on participant outcomes.
This was addressed through a mixed-methods approach, consisting of a broad systematic methods overview across all populations and disease areas. This was followed by a focused methods overview involving complex interventions targeted at older people with frailty. Subsequently, a mixed-methods study within a trial (SWAT) was undertaken to investigate use of an animated video as a strategy to optimise the implementation of a complex intervention in a trial involving older people.
The first systematic methods overview found that most studies reported methods used to measure implementation, however there was little focus on strategies for optimising intervention implementation. This informed the development of the MOSAIC tool which was tested and refined through the second systematic methods overview, which found the tool useful and easy to use. The mixed-methods SWAT found no difference between uptake and engagement rates in the SWAT intervention and control groups. Qualitative interview data found the Personal Independence Coordinator (PIC) to be a motivating factor for service user uptake and engagement.
The MOSAIC tool provides a useful framework for researchers to report implementation of complex interventions within trials. The SWAT showcased a novel use of this methodology for investigating intervention implementation within a trial.
