Work Package 2: Repository of Care Home Trials

Introduction

The NIHR-funded DACHA project is a four-year study led by Professor Claire Goodman at the University of Hertfordshire. The aim is to explore and enhance how resident quality of life and care data are more systematically shared between the multiple health and social care organisations working with care homes, for mutual benefit.

Work Package 2 (WP2) is co-led by Ms. Lisa Irvine (University of Hertfordshire) and Dr Jenni Burton (University of Glasgow), working with Dr Myzoon Ali (University of Glasgow). The aims for WP2 are to:

  1. Create a storage place (repository) for randomised control trials (RCTs) which have taken place in UK care homes.
  2. Use this to inform, going forward, what data could be usefully and routinely collected from UK care homes to help enhance resident quality of life and care.
  3. Make the repository available to other researchers so that its contents can inform other projects.

What is an RCT?

An RCT is a type of scientific (often medical) experiment that is viewed as the best way to test the effectiveness of new treatments.

Why study needed …

Approximately 420,000 people in England and Wales live in a care home, many with multiple health problems and other life-limiting conditions, including 70% with dementia.  Care homes, commissioners and regulators collect and hold a lot of information about residents’ medical history, needs, preferences and care. At present there is no consistent approach to how this is done with consent (including those with dementia) nor how it is used securely. Different people collect different information in different ways, making it difficult to understand the care needs of residents and how these are met as they move between organisations. Consequences include duplication of effort, some needs not being identified or reviewed, feelings of frustration and failures in communication.  At a national level it is difficult to plan for future needs of residents, required treatments and services, and to research their effectiveness. A more consistent approach to how information about care home residents is recorded and handled is needed.  An agreed data set would help researchers and practitioners enhance the care and quality of life for residents, families, and staff.

WP2 will help to inform the study by sharing what typical information about care homes has previously been gathered through RCTs and found to be helpful.

Questions being asked …

This overall study asks:  What is already known about how systems of information (data) sharing between the multiple health and social care organisations working with and for care home residents? How to optimise existing and future collection and use of residents’ data for planning and delivering care and research? What is the minimum amount of information that it is feasible and appropriate to collect routinely and how that can be linked to routinely held information by GPs and hospitals?

Methods being used in WP2 …

There will be four phases: • Phase 1: Identifying UK care home RCTs and establishing a Steering Committee to guide the work • Phase 2: Creating the UK care home RCT repository, preparing and pooling the data from the different RCTs• Phase 3: Analysis of pooled data to inform DACHA study objectives • Phase 4: Preparing the information in the repository to be transferred to another more permanent site (Virtual Trials Archive) for other researchers to use in the future.

Phase 1

To be included in the repository, the RCT must be conducted in a UK care home for adults,

completed and published since2010, involve at least 100 people being studied, have a documented set of rules, able to prove that those involved agreed formally to participate and that the data is trustworthy.  It is important that research leads for participating RCTs feel that they are able to influence the study and benefit from it.  They will be invited to join a steering committee to guide the work.

Phase 2

Only de-personalised data will be kept in the repository, so that data cannot be identified as belonging to an individual. Proper ways of working will be agreed to ensure data are protected from misuse. The quality of the data will also be checked.  Care will be taken to summarise what outcome measures have been collected multiple times, how care home characteristics have been recorded, and contextual aspects of each trial e.g. sample size and follow-up points.

Phase 3

The data in the repository will be analysed for useful information for other researchers (e.g. what are the most popular measures used in care home research). Also the RCTs will be examined to see how how confident we can be that the participants and care homes are similar to other UK care homes, including those not involved in research. The steering committee will be invited to advise on the future uses of the repository data.

Phase 4

The repository will be a legacy of the DACHA study.  After DACHA study funding ends in November 2023, the repository will move to its permanent home at the Virtual Trials Archive, University of Glasgow.  Other researchers will be able to apply to access the data from this point.

Why findings important …

The findings have the potential to deliver a step-change in how we understand the needs of the care home population and measure their quality of life and care.  The repository could be a resource to avoid unnecessary duplication by researchers, but also, those interested in quality improvement in care homes across the country.

Contact

Lisa Irvine, University of Hertfordshire: l.irvine@herts.ac.uk

Work Package 2 is led by Lisa Irvine at University of Hertfordshire and Dr Jenni Burton at University of Glasgow.

Work Package 2 will develop a repository of individual resident data from existing care home trials. Study characteristics (inclusion/exclusion, trial methodology, and intervention details), care home specific details (staff ratios, staff retention, bed size, case mix, ownership) and individual participant level data (demographics, outcome measures, resource use, and medications) will be included in the repository.

Secondary analysis of existing trial data is low-risk and low-cost. Large randomised controlled trials (RCTs) conducted in care homes, whilst costly, provide a rich potential source of data about residents. These RCTs cover a variety of health/care topics (e.g. dementia care, medication management, nutrition, or infection), however there is often overlap in assessment and outcome measures used, and information collected on both residents and the care home structure. Trials in care homes monitor participants regularly, for up to one year. Outcome measures, health resource use, and clinical events, as well as care home characteristics, can therefore be tracked over this period, allowing for longitudinal analysis. If individual patient data (IPD) from existing trials could be pooled, they would collectively provide a large and useful dataset for secondary analysis. Individual patient data (IPD) can be used for exploratory analysis to better understand this population, reduce duplication of effort, and refine future research questions.

In Work Package 2 we aim to develop a repository of individual resident data from existing care home trials. A scoping review identified potential care home trials for inclusion, and we have secured the agreement of eight lead investigators; representing approximately 400 care homes and 6200 residents. Additional trials will be identified through systematic review and snowballing techniques.  The collaboration of trialists will make up the repository Steering Committee, to oversee sharing, combining and repurposing of their existing trial data. Trialists who contribute their data for use in the DACHA study will act as gatekeeper for their respective datasets. All data received will be fully de-personalised, so that only completely anonymised data will be held in the repository.

Based on trial data collated in the repository, we will be able to report key characteristics about care homes and residents, clinical indicators such as hospitalisations, falls, and longitudinal data on several key outcome measures e.g. Barthel; EQ5D; DEMQol, MMSE.  In the absence of other datasets, this repository has the potential to be a research resource and guide further work on assessment and development of core outcome sets for this population.  Our work will be underpinned by the insights from national expert consultation groups, and public involvement, allowing us to prioritise questions for future uses of the repository data.

At the end of the DACHA study, the pooled individual patient data can be made available to other research teams, in user-friendly datasets specific to their explicit research question, through the Virtual Trials Archive at University of Glasgow. The repository will be a research legacy of the programme – a valuable source of high-quality, anonymised, individual participants’ data (IPD) to inform the development of future research, testing of hypotheses and optimisation of study design issues specific to the care home population.

In this ten minute video (featured at the virtual HSRUK2020 conference), Lisa outlines the plans for the repository during the DACHA study and beyond. 17 June 2020.

Further detail provided in the research protocol which is currently under review and available as pre-print on ResearchSquare

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