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Kirsten A. Smith and the Empathica Team

 

Research projects are typically fast-paced, carefully planned and scheduled pieces of work that must fit into a project timeline. They are dependent on knowing what activities are possible with whom, and where. But what happens when the environment changes so dramatically that there is no way to proceed as planned?

The Empathica Project – the Original Idea

Our project was a short feasibility study. Throughout 2019, we had developed online training for doctors, nurses and physiotherapists in primary care, to improve their consultation communication skills. We wanted to test the feasibility of a trial to assess this training, and needed to complete the project by October 2020.

The study would begin in early 2020: GPs would film consultations with patients, do the online training, then film consultations again to see if they had improved. With researchers helping in the waiting room, doctors would recruit their patients to complete questionnaires measuring their experience of clinician communication, their health and wellbeing before and 2 weeks after the consultation, investigating the impact of the doctor’s communication on the patient. The results would test trial procedures to inform a larger trial that could provide evidence for the training’s effectiveness.

In February, our first few practices started the study. The Coronavirus outbreak was on our radar, and we began to make contingency plans. By March, it was clear that the pandemic had taken hold in the UK. On 17 March, we were advised to immediately cease all practice visits – this meant no visits to discuss the study with GPs, distribute video equipment, or recruit patients from the waiting room. We gave all our recruited practices options to reduce or pause study involvement - most chose to pause.

This meant that our entire study was in jeopardy, with barely any data gathered.

Changing Direction

The clinical and research environment had suddenly changed. Our original plans were at best delayed for several months, at worst impossible within the project timeline. We could have given up – written up everything we had done and shelved it.

But several factors persuaded us to continue. Part of a feasibility trial is learning what works and what doesn’t. This includes showing that a trial is possible in a changing environment and can adapt to challenges, demonstrating that the protocol is robust.

Furthermore, feasibility studies aim to show that data collection is acceptable and possible and that a larger trial is worthwhile, not to demonstrate the effectiveness of the intervention (in this case, our online training).   Therefore, we could split our study in two to assess – 1. whether the online training was feasible and 2. whether we could collect patient-reported outcomes.

This was a necessary and potentially beneficial compromise. GP consultations had suddenly changed from mostly face-to-face, to almost exclusively video and telephone consultations. This could significantly impact on patient experience, especially around clinician communication. We had prepared a set of questionnaires on this very topic. So, if we could recruit people without burdening GPs, we could learn about patient experience at a key time of change.

The Plan

We rapidly sought approvals (from ethics and our funder, the SPCR) to amend our study design so that we could use social media to recruit people who had recent GP appointments (by telephone, video or face-to-face) . This enabled us to harness the surge of public interest in COVID Research – an unexpected side effect of an otherwise terrible situation. In parallel, we recruited Primary Care professionals to give us qualitative feedback on the online training.

Making these changes has been challenging and was only possible because of the dedication and agility of our team - including researchers, students and ‘public and patient involvement’ reps, - who have embraced changing roles and new recruitment methods.  Thankfully, everyone’s hard work has paid off.

As of August 2020, we have collected a rich data set from more patients that we had originally proposed.  Furthermore, our data not only tells us about the feasibility of trialling our online training, but also provides a valuable window into patient and practitioner experience of consultations during the pandemic. This will in turn enable us to optimise our online training in the light of changing working practices in primary care resulting from the pandemic.

Positives, negatives and our ever changing world - Final Thoughts

When you conduct research in the field, things can change, sometimes dramatically. As researchers, if we cannot follow the original protocol, we must learn to adapt. We must ask ourselves how we can answer our research questions, and identify what new things can be learned in this ever-changing world.

 

To learn more about Empathica, visit our webpage: https://www.southampton.ac.uk/medicine/academic_units/projects/empathica.page