Care homes are complex settings to undertake research trials. Many expensive, resource-intensive research trials in care homes have not shown any benefit. However, it’s often not clear if this was because the intervention was ineffective, or whether the intervention wasn’t delivered as intended.  Barriers to how a research trial is conducted can threaten its validity, thereby reducing the value to residents, staff, researchers, and funders. For example, in one of the trials, the intervention didn’t engage many of the residents that were most likely to receive a benefit. If these residents had participated, it may have prompted a different result.

In our study we aimed to identify and categorise contextual factors that can play a role in facilitating research trial delivery and factors that act as a barrier. We also aimed to provide recommendations to minimise the risk of expensive failures in the research trial process.

We conducted a review of ‘process evaluations’ that were carried out in parallel to intervention trials. Process evaluations aim to understand how and why an intervention may or may not work in the setting in which it is delivered. To help code the process evaluation data we used a framework that was generated from a Systems Engineering model.  This enabled us to code whether there were facilitators and barriers to the research process that occurred at the level of the resident/staff, the care home environment, the care home organisation, or how the intervention was integrated into daily task routines.

The review is published as an open access paper in Age and Ageing [Contextual factors influencing complex intervention research processes in care homes: a systematic review and framework synthesis]. It provides compelling evidence to undertake and report formal process evaluation data alongside care home trial effectiveness. Exploring contextual factors that influenced the trial outcomes will help maximise the explanatory value of the analysis and provide assurances over a care home trial’s validity and reliability.

Research teams must not underestimate the impact of restructuring normal ways of working for care home staff. The compatibility of the intervention being tested with the care home’s existing work routine was the most prevalent factor that was mentioned in the process evaluations. Both care home staff and members of the research team often made adaptations to and deviations from trial protocols. These factors were compounded by organisational and environment factors: such as high staff turnover, inherent variability of care home administration, resource limitations, and varying suitability of care home internal environments. The culmination of these effects created unanticipated variability between care home settings which prompted significant limitations on the research trial process.

When we looked at all the facilitators and barriers together, we generated a series of themes that captured some important commonalities across the data. The first was ‘procedural drift’. A significant problem we identified is how task-focused activities and staff engagement tended to dwindle over time, often coinciding with when the research team decreased active involvement following the start-up phase. If activities diminished, attention to detail, intervention adherence and commitment to the entire research process weakened also. Inconsistencies in data collection caused research teams to question their reliability.

The second theme indicated a need for ‘participatory action learning’. The interdependent nature of positive working relationships means both the research team and the care home team need work more as a reciprocal partnership. Understanding the properties of the intervention, agreeing its purpose, feeling equipped to enact training, and drawing on prior experience of caring for residents were crucial in engaging and sustaining interest and participation among care home staff.

To help ensure trial interventions in care homes have their best chance of success we developed a tri-fold leaflet that is available to download.  We make suggestions for the research team, the care home team, and activities to be undertaken in collaboration.

In addition to the open-access review paper and the leaflet, Age and Ageing wrote an editorial on the topic entitled: ‘Don’t let the trial kill the intervention’: how can researchers and care home teams implement complex intervention trials in care homes?

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Funding Acknowledgment and Disclaimer: This study/project is funded by the National Institute for Health Research (NIHR) Health Service Research and Delivery programme (HS&DR NIHR127234) and supported by the NIHR Applied Research Collaboration (ARC) East of England. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.