How to know what is working well to prevent COVID-19 in care homes?

COVID-19 has had a devastating impact on people living in care homes, with care home residents accounting for a large proportion of COVID related deaths. A number of trials are underway to test interventions to prevent COVID-19, such as medical treatments. However, it is difficult to compare the findings from these trials to know which intervention is better than the others. It is also important to consider the impact on existing infection control measures, including visiting restrictions. This blog gives an overview of a study, being conducted by researchers at Cardiff University with the Universities of Liverpool and Nottingham, to identify an agreed set of outcomes that clinicians, care home staff, care home residents and their families think are important to consider when assessing the success of an intervention.

Identifying a core outcome set for the evaluation of interventions to prevent COVID-19 in care homes

COVID-19 has had a devastating impact on people living in care homes. Older people living in care homes are particularly vulnerable to COVID-19 illness and death as they are more likely to have long-term conditions such as diabetes, heart disease, blood pressure etc. and have a lower level of immunity to fight infection due to their age. In the first wave of the pandemic in the UK, 40% of COVID-related deaths were accounted for by care home residents. During the second wave, with better testing facilities, preventing staff working across settings and restrictions on visits markedly improve the death rate from 40% to 16% in the period from 31 October until 5 February 2021. This still represents the devastating loss of over 16,000 individual lives so far.

Initially, behavioural and environmental measures such as physical distancing, hand hygeine, use of PPE, and visiting restrictions were adopted to prevent the transmission of COVID in care home settings. The introduction of vaccines and other pharmacological interventions following successful trials have meant that COVID-19 illness and deaths in care home residents are reducing. However, it is still one of the targets of urgent public health research to develop effective interventions to prevent COVID transmission in this vulnerable population. These could include prophylactic medications that could be taken by residents in the event of an outbreak in the care home. This has led to new trials being developed such as PROTECT-CH which has just been launched by the University of Nottingham.

Why the study is needed

One of the challenges of having a range of interventions for the prevention of COVID-19 is that it is difficult to compare the effectiveness between different trials. Trials often use different outcomes to measure whether their intervention is effective or not such as rates of infection in residents (and staff), how many become unwell, and how many die either due to COVID-19 or from other causes. We would be able to compare the effectiveness (and any harms or negative impacts) if there was agreement on which outcomes should be measured. In order to do this, we need to carefully select a minimum or core set of outcomes (a COS) which should be measured in all trials of interventions to prevent COVID-19 in care homes. It is also important that the outcomes measured in trials are those that really matter to the people who live and work in care homes, such as their well being and quality of life. Therefore the selection of core outcomes must be made by a diverse range of stakeholders to ensure that the most important and relevant outcomes are included.

A COS for COVID-19 prevention interventions in the general population has already been developed. COS-COVID-P is a minimum set of outcomes for prevention studies worldwide but this was not targeted to any specific setting. Preventiing COVID-19 is much more challenging in a care home setting due to the vulnerability of residents, many of whom have multiple long term conditions and cognitive impairment, with factors such as communal living and variable access to testing for staff and residents. This has led to the need to develop a separate COS targeted particularly to this setting.

Developing a core outcome set

The Centre for Trials Research at Cardiff University is now working with the Universities of Liverpool and Nottingham to conduct the COS-COVID-PCARE project https://www.comet-initiative.org/Studies/Details/1810 to establish a set of core outcomes that should be measured, at a minimum, in all trials of COVID-19 prevention in care homes. Due to the rapid progress of prevention and treatment strategies for COVID-19, we are using a rapid response approach that follows on from the development of COS-COVID-P.

The first part of the study has been to review the outcomes that are currently being used in trials of interventions to prevent COVID-19 in care homes. These have been gathered together in a list of potential outcomes to include in the COS.

We are now conducting an online Delphi survey (over two to three rounds) and asking a range of different stakeholders to take part and rank the outcomes that they consider to be the most important to include. There is also the opportunity to suggest outcomes that they consider to be important to include that are not already on the list. The survey will then be followed by an online consensus meeting to agree on the ‘core outcomes’ to be included.

Can you help?

We are trying to ensure that a wide range of different perspectives are represented.

We would love to hear from you if you are:

• A resident of care homes or their relative or friend
• A manager or a member of staff currently working in a care home in the UK
• A clinician, researcher or an allied healthcare professional working for a care home or interested in COVID prevention in care homes
• A representative from the care service regulation or a policymaker

We would like to invite you to participate in the 1st round of our Delphi survey. It may take 10-15 minutes to complete the survey and all information will be anonymous.

Please click on the following link to access the survey: https://delphimanager.liv.ac.uk/COSCOVIDPCARE/Delphi

To read more information about the survey and to participate, please visit https://www.comet-initiative.org/Studies/Details/1810