COS-COVID-PCARE

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

Background

COVID-19 has had a devastating impact on people living in care homes, including older people and people with a learning disability, who are at a significantly increased risk of death due to COVID-19. In the first wave of the pandemic in the UK, 40% of COVID-19 related deaths were accounted for by care home residents. Internationally, almost half of all COVID-19 deaths have occurred in care homes.

Methods to prevent COVID-19 and reduce transmission in care homes include interventions such as infection control measures which include the use of PPE and visiting restrictions. However, these measures have a significant impact on the physical and mental wellbeing of care home residents. Pharmacological interventions (such as prophylaxis drugs or antibody preparations) may help to prevent COVID-19 infection and transmission in care home settings and these and other non-pharmacological interventions are being testing in a number of clinical trials.

When assessing how effective these interventions are, researchers must decide which ‘outcome’ measure to use in their trials. Poor choices can lead to the use of outcomes that are not those that people living in care homes, and those who care for them, regard as most important or relevant.

As this is a new disease, currently there is no agreement about what outcomes should be measured when testing interventions such as drugs, vaccines, and infection control measures which aim to prevent the transmission of COVID-19 in care homes. Developing an agreed set of outcomes could make it easier for the results of these trials to be compared, contrasted and combined as appropriate.

Study aim

The aim of this study is to develop an agreed set of outcomes for trials testing the effectiveness of interventions to prevent COVID-19 in care homes. A core outcome set (COS) represents the minimum that should be measured and reported in trials of a specific condition or context. This study builds on a previous COS for COVID-19 disease prevention in the general population (COS-COVID-P) to develop a supplementary specific module for COVID-19 prevention in care homes. The study has been registered on the COMET database.

Study design

We will use a rapid response approach that follows on from the development of COS-COVID-P and uses established COS development methods.

COS COVID PCARE will be conducted in three stages:

Stage 1

Registered trials for the prevention of COVID-19 will be reviewed and studies involving care homes or relevant to the care home context will be identified in order to generate the list of candidate outcomes and domains.

Stage 2

An online Delphi survey will be conducted over 2-3 rounds with a range of relevant stakeholder groups. This includes family members of care home residents, researchers involved in the design and conduct of trials in care homes, healthcare professionals, and care home providers, managers and staff. Participants will be asked to rank the candidate outcomes according to how important they feel it is to include them in the COS. They can also suggest other important outcomes that they think are missing from the list.

Stage 3

Following the Delphi survey, the final stage will be an online meeting with key stakeholder participants from the survey to reach consensus on the items to be included in the core outcome set. The main aim of the consensus meeting will be to determine consensus (in or out) for those items that did not reach consensus in the survey or where further consultation and discussion with stakeholders is required.

Involving the public and patients

Members of the public are part of the Steering Committee for the project, as well as contributing their experience through the Delphi survey and consensus meeting. By involving people with personal experience of care homes we aim to ensure that the outcomes are relevant and important to all those involved.