Work Package 2

Repurposing of clinical trial data: Developing a Repository of Care Home Trials

Secondary analysis of existing trial data is low-risk and low-cost. Large randomised controlled trials (RCTs) conducted in care homes, whilst costly, provide a rich potential source of data about residents. These RCTs cover a variety of health/care topics (e.g. dementia care, medication management, nutrition, or infection), however there is often overlap in assessment and outcome measures used, and information collected on both residents and the care home structure. Trials in care homes monitor participants regularly, for up to one year. Outcome measures, health resource use, and clinical events, as well as care home characteristics, can therefore be tracked over this period, allowing for longitudinal analysis. If individual patient data (IPD) from existing trials could be pooled, they would collectively provide a large and useful dataset for secondary analysis. Individual patient data (IPD) can be used for exploratory analysis to better understand this population, reduce duplication of effort, and refine future research questions.

In Work Package 2 we aim to develop a repository of individual resident data from existing care home trials. A scoping review has identified potential care home trials for inclusion, and we have secured the agreement of five lead investigators; representing approximately 250 care homes and 4300 residents. Additional trials will be identified through systematic review and snowballing techniques.  The collaboration of trialists will make up the repository Steering Committee, to oversee sharing, combining and repurposing of their existing trial data. Trialists who contribute their data for use in the DACHA study will act as gatekeeper for their respective datasets. All data received will be fully de-personalised, so that only completely anonymised data will be held in the repository. 


Based on trial data collated in the repository, we will be able to report key characteristics about care homes and residents, clinical indicators such as hospitalisations, falls, and longitudinal data on several key outcome measures e.g. Barthel; EQ5D; DEMQol, MMSE.  In the absence of other datasets, this repository has the potential to be a research resource and guide further work on assessment and development of core outcome sets for this population.  Our work will be underpinned by the insights from national expert consultation groups, and public involvement, allowing us to prioritise questions for future uses of the repository data. 


At the end of the DACHA study, the pooled individual patient data can be made available to other research teams, in user-friendly datasets specific to their explicit research question, through the Virtual Trials Archive at University of Glasgow. The repository will be a research legacy of the programme – a valuable source of high-quality, anonymised, individual participants’ data (IPD) to inform the development of future research, testing of hypotheses and optimisation of study design issues specific to the care home population.