The feasibility of undertaking a complex intervention trial in English care homes

Background: The health and well-being of care home residents is under-researched, but studies in care home settings are complex and many researchers report methodological challenges. Aims: 1) identify systematically the challenges in conducting intervention research in care homes in the British Isles; 2) explore empirically, within a trial, the research challenges in this setting and thereby make recommendations for research practice. Literature review: To frame my empirical studies I systematically searched the literature for methodological and practical challenges that intervention-researchers have faced in care homes. Empirical study methods: I adopted a pragmatic perspective, using a multi-method approach to explore identified challenges. Qualitative and quantitative data were collected to: understand the challenges of intervention delivery; explore how to monitor intervention uptake in care homes; investigate data collection methods; investigate people’s experiences of providing data; and explore alternative data collection approaches. Study findings: Modifiable factors were identified which influence staff engagement with training; monitoring staff members’ use of new skills through non-expert observation was difficult. Data acquisition worked well when researchers collected data directly from care notes or from staff, but return rates were poor for self-completed data. Good compliance masked inaccuracies in the dataset due to: staff having difficulty making proxy judgements about residents; outcome measures being inappropriate for residents; and care notes being complex to navigate, misaligned with research requirements, and incomplete when compared to NHS-derived data. Many residents could not provide data due to cognitive impairment; better data return rates came from researcher observation, although there were some concerns about accuracy. Implications: I explored reported challenges in care home research in more detail, identifying reasons behind some of these difficulties. I suggest ways to adapt and refine methods to enhance care home engagement, optimise staff training, and tailor data collection approaches to the needs of the care home environment.