The better health in residents in care homes study: Pilot study
| ISRCTN | ISRCTN74109734 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74109734 |
| Secondary identifying numbers | 35749 |
- Submission date
- 06/11/2017
- Registration date
- 10/11/2017
- Last edited
- 05/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Early detection and intervention for ill health in residents in care homes with nursing is problematic. People living in care homes can be admitted to hospital for conditions which, if noticed and treated earlier, could be managed in the care home. The Better Health in Residents in Care Homes (BHiRCH) programme aims to reduce rates of avoidable hospital admissions from care homes (with nursing) for respiratory infections, urinary tract infections, dehydration and acute exacerbation of chronic heart failure by ensuring early detection and early intervention. This has the potential to prevent an emergency presentation to hospital. This project is focused on these four conditions which are responsible for a large proportion of unplanned hospitalisations. Our Programme Development Grant identified multi-component interventions which, when tested in other nursing homes, showed promise in reducing avoidable admissions. The aim of the research is to identify whether a further definitive study is warranted.
Who can participate?
Residents aged 65 and older of care homes.
What does the study involve?
The BHiRCH programme comprises the following components: Early Warning Tool (Stop and Watch Early Warning Tool), Care Pathway (clinical guidance and decision support system), Structured method for communicating with primary care, Knowledge and skills development for care home staff and family members, close friends or care partners, Family members, close friends or care partners’ involvement, and implementation support. Nursing homes are randomly allocated one of two groups. Those in the first group receive the usual care. Those in the second group receive the BHiRCH programme. Two nurses within each home become Practice Development Champions who are trained to implement the intervention, and these nurses are supported by a Practice Development Support Group. Number of avoidable hospital admission are recorded along with other data collected from staff, residents and care partners through questionnaires.
What are the possible benefits and risks of participating?
Participants may value speaking to the research team about their experiences. There are no direct risks however participants may become tired when answering the questionnaires. Participants are invited to let the researcher know and participants can take a break, re-schedule or stop taking part in the study.
Where is the study run from?
This study is being run by University College London (UK) and takes place in 14 care homes across Yorkshire and London.
When is the study starting and how long is it expected to run for?
April 2017 to April 2019
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Professor Murna Downs
m.downs@bradford.ac.uk
Contact information
Public
Centre for Applied Dementia Studies
Faculty of Health Studies
University of Bradford
Bradford
BD7 1DP
United Kingdom
| Phone | +44 1274 233991 |
|---|---|
| m.downs@bradford.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Screening, Diagnosis, Prevention, Complex Intervention, Management of Care, Active Monitoring |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN74109734_PIS_11Oct17_V3.pdf |
| Scientific title | BHiRCH: Pilot cluster randomised trial of an evidence based intervention to reduce avoidable hospital admissions in residents in care homes (the Better Health in Residents in Care Homes study) |
| Study acronym | BHiRCH |
| Study objectives | The Better Health in Residents in Care Homes (BHiRCH) programme is developing an intervention that aims to reduce rates of avoidable hospital admissions from care homes (with nursing) for respiratory infections, urinary tract infections, dehydration and acute exacerbation of chronic heart failure by ensuring early detection and early intervention. The aim of this pilot trial is to test study procedures and outcome in order to assess whether a further definitive study is warranted. |
| Ethics approval(s) | Queen Square Research Ethics Committee, 18/10/2017, ref: 17/LO/1542 |
| Health condition(s) or problem(s) studied | Specialty: Ageing, Primary sub-specialty: Ageing; UKCRC code/ Disease: Generic Health Relevance/ No specific disease |
| Intervention | The intervention is implemented at the level of the whole care home. The BHiRCH programme is a complex intervention, with 4 key components. These are: 1. Early Warning Tool (Stop and Watch Early Warning Tool) 2. Care Pathway (clinical guidance and decision support system) 3. Structured method for communicating with primary care (SBAR) 4. Implementation support- practice development champions and support groups. This is a cluster randomised trial conducted in 14 nursing homes. The 14 homes arerandomised 1:1 between intervention and “usual care”, stratified by location. Randomisation is undertaken by an independent statistician from the CTU using a statistical programme called SAS. All homes are randomised at the same time, just prior to the intervention starting. The intervention takes place over 12 months, with a pre-intervention period of three months for recruitment and baseline data collection, and a post-intervention period of one month for completion of outstanding data collection. This intervention acts upon a group of people (the nursing home staff who work with residents and their family carers) and thus the nursing home is the unit of intervention, allocation and analysis. Staff in nursing homes receiving the intervention receive training in the use of a new method of detecting, assessing and communicating changes in the health of residents. Staff, residents and family members may also opt in to individual level data collection, in which further information about their quality of life, perspectives on the care home, and usual care are collected. The CONSORT guidelines for the reporting of randomised trials are followed however, given that this is a pilot study, the analysis will be mainly descriptive and will focus on the recruitment, participant characteristics, other baseline and outcome variables, loss to follow-up and any adverse events. Descriptive analysis of all the data (including the completeness of data collection) is done and the rates of hospital admission for ACS conditions and other important outcomes are compared between the control and intervention groups through the calculation of confidence intervals. |
| Intervention type | Other |
| Primary outcome measure | Reduction in avoidable acute hospital admissions for respiratory infections, urinary tract infections, dehydration and exacerbation of chronic heart failure. The number of hospital admissions will be recorded from care home records. Residents who have been hospitalised and have consented to individual level data collection will be eligible for analysis for this outcome. Their care records will be analysed using the SIRR tool, and this data will be further assessed by an expert panel of geriatricians to identify whether the hospitalisation was avoidable. This assessment will be carried out shortly after the hospitalisation of any resident. |
| Secondary outcome measures | 1. Establish whether resident consent procedures allow the collection of sufficient individual level data using the number of residents who have consented at the end of the Pilot Trial 2. Effectiveness of the implementation strategy is assessed using qualitative data on barriers and facilitators to implementation. This will be recorded from telephone calls with Practice Development Champions on a monthly basis, and from qualitative interviews with care home staff at the end of the Pilot Trial 3. fidelity to the intervention is assessed using research field notes from telephone calls with Practice Development Champions on a monthly basis, and from qualitative interviews with care home staff at the end of the Pilot Trial 4. The level of nursing home staff engagement with the intervention is assessed using qualitative interviews with care home staff at the end of the Pilot Trial, and the number of recorded usage of the intervention tools (on a monthly basis) 5. Sustainability of the intervention outside the context of a trial is assessed using qualitative interviews with nursing home staff (at the end of the Trial) and researcher field notes on support provided, from monthly telephone calls with Practice Development Champions 6. Potential primary and secondary outcomes for a definitive trial are assessed using an analysis of the completeness of data at the end of the pilot trial 7. Cost and outcome data is measured using an economic evaluation based on prescription medication usage and the CSRI tool, collected monthly from residents who have consented 8. Probability of the intervention being cost-effectiveness is assessed using an analysis of prescription medication usage, CSRI data and staff time spent on the intervention, collected monthly from resident care home data and telephone calls with staff 9. Key cost components through economic analysis and the expected value of perfect information (EVPI) is assessed using an analysis of prescription medication usage, CSRI data and staff time spent on the intervention, collected monthly from resident care home data and telephone calls with staff 10. Completeness of data collection is assessed using the completion of documentation and return rate of questionnaires on a monthly basis throughout the trial |
| Overall study start date | 03/04/2017 |
| Completion date | 30/05/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 700; UK Sample Size: 700 |
| Key inclusion criteria | 1. The study implements an enhanced version of usual care and because of the clustered nature of the setting this will be implemented across the care home. All residents will be invited to be involved in the collection of individual level outcome data. 2. Aged 65 and older |
| Key exclusion criteria | 1. Residents receiving end of life treatment or palliative care, under the age of 65, those who are not english speaking or those who have stated they do not wish to be involved in research 2. Care partners will be excluded from the project, and no more data will be collected if their relative/friend passes away during the project |
| Date of first enrolment | 31/10/2017 |
| Date of final enrolment | 26/01/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
E10 7EL
United Kingdom
Enfield
EN3 5UJ
United Kingdom
Enfield
EN1 2QN
United Kingdom
London
N18 1SH
United Kingdom
London
E10 7EB
United Kingdom
London
E6 3PD
United Kingdom
Harrogate
HG2 8JT
United Kingdom
Knaresborough
HG1 4DW
United Kingdom
Fulford
YO10 4HN
United Kingdom
Leeds
LS8 1DH
United Kingdom
Sponsor information
University/education
1st Floor Maple House
149 Tottenham Court Road
London
W1T 7DN
England
United Kingdom
"ROR" |
https://ror.org/02jx3x895 |
|---|
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 | 01/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | We will publish a protocol paper in 2018, and a paper on the effectiveness and cost-effectiveness of the intervention in late 2019. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version V3 | 11/10/2017 | 14/09/2018 | No | No |
| Participant information sheet | version V3 | 11/10/2017 | 01/04/2019 | No | Yes |
| Protocol article | protocol | 27/05/2019 | 19/02/2020 | Yes | No |
| Results article | results | 01/02/2021 | 05/03/2021 | Yes | No |
| Results article | results | 13/12/2020 | 05/03/2021 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN74109734_PROTOCOL_V3_11Oct17.pdf
- 14/09/2018: Protocol file uploaded
- ISRCTN74109734_PIS_11Oct17_V3.pdf
- Uploaded 01/04/2019
Editorial Notes
05/03/2021: Publication reference added.
19/02/2020: Publication reference added.
01/04/2019: The participant information sheet has been uploaded.
14/09/2018: Uploaded protocol Version 3 11th October 2017 (not peer reviewed).
13/03/2018: Professor Murna Downs replaces Dr Alan Blighe as primary study contact.
19/02/2018: The overall trial end date has been updated from 30/04/2019 to 30/05/2019. The recruitment end date has been updated from 25/01/2018 to 26/01/2018.
10/11/2017: Internal review.
