Contact tracing in care homes using digital technology for improving infection control including COVID-19
| ISRCTN | ISRCTN11204126 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11204126 |
| IRAS number | 292204 |
| Secondary identifying numbers | CPMS 47853, IRAS 292204 |
- Submission date
- 29/01/2021
- Registration date
- 17/02/2021
- Last edited
- 07/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
The COVID-19 pandemic has had a tragic impact on the ~411,000 older people that live in 15,517 care homes in England and Wales. Even with a vaccine the levels of immunity and optimal immunisation regimen for the very elderly will likely differ from the (younger) general population. Pandemic infection rates within homes have been as high as 80%, and mortality rates as high as 30-50% - infection control and effective management of contacts between staff, residents and visitors in homes will be key to managing and containing COVID-19.
Conventional interviews and documentary-based contact tracing are likely ineffective in care homes. Many homes have 70-80% of residents with memory and cognitive limitations and staff often have more than 50 contacts per day. Recalling historic contacts using interviews is unfeasible.
Wearable digital devices may help improve contact tracing in care homes. Advances in network technology mean small, discrete, wearables, with long battery lives can easily capture, store and recall the information required for contact tracing: when, who, where, how long and frequency of contacts.
Researchers are undertaking a large-scale cluster randomised trial in care homes in Yorkshire and the East Midlands to test whether wearable digital contact tracing devices and tailored feedback of results (CONTACT intervention) are a cost-effective means of generating contact data in care homes, improving infection control and COVID-19 resident infection rates and mortality, compared with contact tracing as usual. They are not aware of any rigorously evaluated non-smartphone-based digital device contact tracing empirical studies. Before the definitive trial, the researchers will assess the acceptability and feasibility of intervention delivery processes and trial design/implementation in a single-arm feasibility study in two care homes.
Who can participate?
Six care homes in West Yorkshire have been selected to take part in “extended feasibility” work. All residents, staff, and visitors within these homes will be able to take part if eligible, and willing to do so.
What does the study involve?
The study involves all consenting participants (residents, staff, and visitors) wearing a small button-type device on a key fob or watch strap that will record contacts (person-to-person or person-to-location), and additional data collection (collected from Care Home CONTACT Lead) to support the study evaluation.
What are the possible benefits and risks of participating?
It is hoped that this study will provide information on how small, wearable devices can be used by care homes to reduce the risks of COVID-19 infection transmission. The researchers do not expect there will be any direct risks or disadvantages to taking part.
Where is the study run from?
University of Leeds (UK)
When is the study starting and how long is it expected to run for?
October 2020 to May 2022
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Prof. Carl Thompson
c.a.thompson@leeds.ac.uk
Contact information
Scientific
Chief Investigator
University of Leeds
School of Medicine and Health
Leeds
LS2 9JT
United Kingdom
| Phone | +44 (0)7939254863 |
|---|---|
| c.a.thompson@leeds.ac.uk |
Study information
| Study design | Both; Design type: Prevention, Process of Care, Device, Complex Intervention, Management of Care, Active Monitoring, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | ISRCTN11204126_PIS_V2.0_12Nov20.pdf |
| Scientific title | CONtact TrAcing in Care homes using digital Technology (CONTACT) – a non-randomized feasibility study |
| Study acronym | CONTACT feasibility study |
| Study hypothesis | Testing of staff and residents without contact tracing will not be enough for effective public health interventions and reduced community transmission. Conventional structured interview and documentary contact tracing is likely ineffective in care homes. In the many homes where 70-80% of residents live with dementia and staff have more than 50 contacts per day recalling historic contacts using interviews is unfeasible. NHS Test and Trace-style contact tracing is labour intensive, inefficient and burdensome for contacts and tracers alike. Smartphone-based solutions to support contact tracing have limited utility even in the general population, but have even less in care homes – where few residents use such technology and staff are sometimes discouraged from using them in the workplace. Wearable digital devices can help overcome the flaws in contact tracing in care homes using human tracers and smartphones. Advances in network technology mean small, discrete, wearables, with a battery life of up to a year can capture contacts between individuals and their environments. Key information for contact tracing (when, who, where and how long and frequency of contacts) is easily generated, stored and recalled. Lightweight tags on lanyards, clothing or wristbands, often used already in homes for access control and resembling fitbits™, make real-time and retrospective capture, encryption, storage and recall of contacts realistic. The researchers are planning to evaluate, through a large scale cluster randomised trial in care homes in West Yorkshire and the East Midlands, whether wearable digital contact tracing devices and tailored feedback of results (CONTACT intervention) are a cost-effective means of generating contact data in care homes, improving infection control and COVID-19 resident infection rates and mortality, compared with contact tracing as usual. Although contact tracing devices are widely used in manufacturing and other high-risk industries and have been used in academic research contexts they are mostly enacted in the form of smartphone or other “smart” device apps that make use of Bluetooth and similar facilities. Systematic reviews suggest such approaches are limited by (low or partial) take up and empirical evidence of benefits are scarce. Whilst mooted as an industry “solution” to the problems of care home-based contact tracing the researchers are not aware of any rigorously evaluated non-smartphone-based digital device contact tracing empirical studies. Whilst devices are beginning to be used in small scale industry context, evaluations have been restricted to simulation-based modelling. Therefore, prior to the definitive trial the researchers will assess the acceptability and feasibility of intervention delivery processes, and trial design/implementation, in a single-arm feasibility study, in two care homes. |
| Ethics approval(s) | Approved 23/11/2020, Yorkshire and Humber – Bradford Leeds SCREC (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)2071048083; bradfordleeds.rec@hra.nhs.uk), REC ref: 20/YH/0326 |
| Condition | COVID-19 (SARS-CoV-2 infection) |
| Intervention | The CONTACT feasibility study (in preparation for large cluster randomised control trial) is a single-arm non-randomized trial, taking place across two care homes in West Yorkshire, with approximately 400 frontline staff, residents and visitors. In accordance with the intended cluster design for the main trial, permission will be sought from each Care Home manager (or delegate) to participate in the study and implement the contact tracing system as a new standard of care within the home. CONTACT is a whole-home intervention – all residents, staff and visitors within the home will be eligible for the intervention except for those residents for whom the wearable device would constitute a risk of harm as assessed by care home manager (or delegate). Those eligible will be invited to wear the CONTACT intervention device for the duration of the study, but this will not be compulsory. Reasons for non-wear will be documented. Each wearable device has a unique ID. The wearable device scan for other devices nearby and records the other device ID, signal strength (proxy for distance), duration and timestamp. If devices have been in close contact, a “proximity event” will be stored on the device, and this will be transmitted to Microshare with the device IDs. No personal information is stored on the device. Data received from Microshare (proximity events/signal strength/battery life/date and time) will be shared with researchers at the University of Leeds, who will process it to develop tailored feedback reports on contact patterns and trends (for example, decreasing/increasing staff-resident contacts, location of contacts, number of ‘close’ (current guidance <2 m – 15 min) contacts, or increasing/decreasing compliance with contact-related infection control) for each home. Researchers will support care homes to understand the reports, and data within the reports, to help inform their infection control measures. The researchers will explore the feasibility of developing and utilising Microshare dashboards, and make available to the care homes to provide real-time data on contacts. Homes will maintain details (via a database or paper-based system) of device IDs assigned to each resident, staff and visitor. Information on COVID-19 test results, and changes in residents. Including residents leaving and joining the home, and deaths. Care home, resident and staff demographics will be recorded to aid in the interpretation of the findings. The research team will be responsible for installation, training and ongoing support. Staff will be invited to take part in interviews to explore knowledge and experience with the use of device, feedback and data collection. Data on this will be recorded. Mechanisms to combine information from CONTACT with wider NHS and PHE processes will be explored. The project PI will contact local Directors of Public Health, Health Protection Teams and Test and Trace leads, making them aware of the study and the ability to provide them with detailed within-home contact information on request from them or as a result of a positive test in the home and the desire of external (to the home) test and trace infrastructure for contact information. Contact data will be collected over a minimum of 2 months from installation of the devices, to inform progression to the cluster Randomised Controlled Trial (cRCT). The researchers propose to continue collecting data on the acceptability of feedback reports in these two homes for up to 12 months to allow homes to further make use of the technology to work with the homes as a testbed for working hypotheses developing as a result of the study or from approaches from other COVID-19 research (subject to approval). The researchers will also use a range of methods to explore intervention implementation within the two care homes. Methods will be based on Normalisation Process Theory (NPT) and its approach to explaining and predicting the embedding of CONTACT technology in work “as done” (rather than imagined), and will explore: 1. Implementation: the structures, resources and processes by which delivery of CONTACT is achieved, and the quantity and quality of what is delivered 2. Mechanisms of impact: how CONTACT intervention activities, and participants’ interactions with them, trigger change 3. Context: how external factors influence the delivery and functioning of CONTACT wearables, feedback and information use Operationally, this is likely to include: CONTACT researchers and Chief Investigator building a relationship with a study champion in each care home to: 1. Formally using an interview schedule adapted from NPT’s NOMAD questions and four key constructs 2. Informally, via regular support calls to each care home, including after receipt of their tailored analysis To identify participants (staff, residents, and visitors) willing to undertake a brief telephone interview the researchers will ask participants to indicate their willingness to be approached by one of the research team at device allocation. If sampled for participation in interviews the care home manager (or delegate) will be asked to issue an information sheet (Participant Summary_Interviews) to potential participants and confirm continued acceptability of researcher contact. If agreeable, the care home manager (or delegate) will support arrangements for researcher contact to discuss participation and support the process for obtaining written informed consent to interviews. The researchers will seek written informed consent from all participants sampled to undertake interviews. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | CONTACT |
| Primary outcome measure | Proof of feasibility for the main trial: 1. Ease of administering the devices to people living and working in the care home, as well as family caregivers, healthcare professionals and external visitors to the home, assessed using Likert scale on ease of use across participants at 2 months following contact tracing system activation 2. The feasibility of completing the associated paperwork, including the linkage of devices with individual identities for residents, staff and visitors, assessed using CRF compliance at 2 months following system activation 3. The acceptability of wearing the devices and reasons for non-wear, assessed by completion of CRFs linked to device allocation and percentage of active devices at 2 months following system activation 4. Loss/breakage/replacement requirements in a 1-month period assessed by completion of CRFs linked to device allocation at 2 months following system activation 5. The feasibility of proposed methods of CONTACT tracing feedback assessed by qualitative feedback/interview at 2 months following system activation 6. Barriers to being a study champion in the sites assessed using qualitative interviews at 2 months following system activation 7. The feasibility of conducting phone calls to intervention homes assessed using contact history and determination of success at 2 months following system activation 8. Data transmission software (transfer-reading of data at trials unit; storage; analysis) assessed using manual verification with device allocation CRFs during the active study period 9. The feasibility of collecting the primary outcome data for the definitive study assessed using compliance reporting of data capture methods at 2 months following system activation |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/10/2020 |
| Overall study end date | 31/05/2022 |
Eligibility
| Participant type(s) | Healthy volunteer, Health professional, Resident |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | Planned Sample Size: 400; UK Sample Size: 400 |
| Total final enrolment | 783 |
| Participant inclusion criteria | 1. Resident, staff member or visitor at participating care home 2. Willing to take part, and wear contact tracing device during presence in care home |
| Participant exclusion criteria | 1. Wearing a contact device would constitute a risk of harm 2. Aged under 16 years |
| Recruitment start date | 05/01/2021 |
| Recruitment end date | 09/03/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
27 Hunslet Hall
Leeds
LS11 6TT
United Kingdom
The Green
Seacroft
Leeds
LS14 6PA
United Kingdom
Leeds
LS12 5HA
United Kingdom
Haigh
Barnsley
S75 4DB
United Kingdom
Bishopthorpe Road
York
YO23 1DE
United Kingdom
Fulford
York
YO10 4HN
United Kingdom
Sponsor information
University/education
Clare Skinner
Faculty Research Office
Faculty of Medicine and Health
L9 Worsley Building
Leeds
LS2 9JT
England
United Kingdom
| Phone | +44 (0)1133437587 |
|---|---|
| governance-ethics@leeds.ac.uk | |
| Website | http://www.leeds.ac.uk/ |
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Protocol to be available on the study website: https://ctru.leeds.ac.uk/contact 2. As this is feasibility work the researchers have yet to determine if protocol and SAP papers will be published – main trial documents will be published 3. Planned publication in a high-impact peer-reviewed journal by January 2024 |
| IPD sharing plan | Data supporting this work are available on reasonable request. All requests will be reviewed by relevant stakeholders, based on the principles of a controlled access approach. Requests to access data should be made to CTRU-DataAccess@leeds.ac.uk in the first instance. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V2.0 | 12/11/2020 | 17/02/2021 | No | Yes |
| Participant information sheet | version V3.1 | 23/11/2020 | 17/02/2021 | No | Yes |
| Protocol file | version V3.1 | 23/11/2020 | 17/02/2021 | No | No |
| Plain English results | 14/06/2023 | 16/06/2023 | No | Yes | |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | Process evaluation | 04/12/2023 | 05/12/2023 | Yes | No |
| Other publications | Performance of the wearable devices in care home environments | 08/09/2023 | 25/06/2024 | Yes | No |
| Other publications | Quality in care home; the value of wearable-enabled devices for quality improvement in care homes | 15/05/2024 | 25/06/2024 | Yes | No |
| Preprint results | 12/10/2023 | 25/06/2024 | No | No | |
| Results article | Feasibility and acceptability | 02/10/2024 | 07/10/2024 | Yes | No |
Additional files
- ISRCTN11204126_PROTOCOL_V3.1_23Nov20.pdf
- Uploaded 17/02/2021
- ISRCTN11204126_PIS_V2.0_12Nov20.pdf
- Uploaded 17/02/2021
- ISRCTN11204126_PIS_V3.1_23Nov20.pdf
- Uploaded 17/02/2021
- ISRCTN11204126_ResultsPlainEnglish_14June2023.pdf
Editorial Notes
07/10/2024: Publication reference added.
25/06/2024: Publication references added.
05/12/2023: Publication reference added.
16/06/2023: Results in plain English uploaded.
05/10/2022: The following changes have been made and the plain English summary has been updated accordingly:
1. The overall trial end date has been changed from 31/01/2023 to 31/05/2022.
2. The total final enrolment was added.
3. The recruitment end date has been changed from 01/12/2021 to 09/03/2022.
4. Manor House Residential Home, The Old Chapel Care Home, The Chocolate Works Care Village and Fulford Nursing Home have been added to the trial participating centres.
17/02/2021: Uploaded protocol Version 3.1, 23 November 2020 (not peer reviewed). The participant information sheet has been uploaded.
29/01/2021: Trial's existence confirmed by the NIHR.
