Exploring how to enable care homes in the UK to use the Action Falls Programme (Formerly GtACH) in day-to-day care

ISRCTN ISRCTN79131660
DOI https://doi.org/10.1186/ISRCTN79131660
IRAS number 310091
Secondary identifying numbers CPMS 51826, IRAS 310091
Submission date
29/03/2022
Registration date
19/04/2022
Last edited
17/03/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Background and study aims
People who live in care homes are at great risk of falling. Falls are common, harmful, costly, and difficult to prevent. The Action Falls programme (formally GtACH) trains and supports care home staff to identify the reasons why residents fall and then guides them to complete Actions to reduce falls. In a large multicentre randomised controlled trial called the FinCH trial, the Action falls programme was cost-effective and reduced falls by 43%. Therefore, the Action Falls programme has already demonstrated its effectiveness. The aim of this study is to examine what helps and what hinders its use in Care homes for day-to-day care.

Who can participate?
We are working with four regions – East Midlands, West Midlands, South London and the North-East - to develop and research ideas about how to put the Action falls programme into use nationwide. We are looking to work with 60 care homes across these regions representing a mixture of registrations, size and management structure.

What does the study involve?
Participating in the study involves:
• Using the Action falls programme for 12 months: This involves staff training on using Action Falls,
• Taking part in up to 3 Action Collaboration Events which will bring care home and healthcare staff together to develop and research ways to implement Action falls.
• Providing anonymised data on the number of falls in the care home per month.
• Care home employees will be invited to fill out a multiple-choice questionnaire on two occasions, about their experiences of using Action Falls.
• Some care home staff (up to 48 in total) will be invited to take part in an interview about their experiences of using Action Falls

What are the possible benefits and risks of participating?
There are no specific personal benefits to taking part in this study. However, views from these interviews will support the use of the Action Falls programme as a way of reducing resident falls in care homes. All care home staff who take part in two surveys or attend an Action Falls Collaborative event will receive a shopping voucher as a thank you for their time.
There are no direct risks in taking part in this study. If during the study participating care home staff tell researchers about care which is harmful, researchers will be required to report to the Adult Safeguarding Committee and care home management who may wish to explore this further.

Where is the study run from?
University of Nottingham (UK)

When is the study starting and how long is it expected to run for?
October 2021 to September 2024

Who is funding the study?
NIHR Applied Research Collaboration for Wessex (UK).

Who is the main contact?
Dr Fran Allen, frances.allen@nottingham.ac.uk

Contact information

Dr Fran Allen
Scientific

University of Nottingham Medical School
B114
QMC
Nottingham
NG7 2UH
United Kingdom

ORCiD logoORCID ID 0000-0001-7265-0676
Phone +44 115 8230228
Email frances.allen@nottingham.ac.uk

Study information

Study designInterventional non-randomized
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet. sandra.burgess@nottingham.ac.uk
Scientific titleImplementation of the ACTiON FALLS prevention programme (formally GtACH) into UK care homes
Study acronymFinCH Implementation Study
Study hypothesis1. How do care homes (and parent organisations) best implement the ACTiON FALLS programme?
2. What are the real-world barriers and facilitators to care homes when using ACTiON FALLS?
3. Can ACTiON FALLS yield the same successful trial outcomes and how is this sustained (opportunity costs)?
4. How do we increase spread and uptake of ACTiON FALLS?
5. How do care home staff remain skilled to use the ACTiON FALLS programme?
Ethics approval(s)Approved 14/02/2022, (), ref: 22/EM/0035
ConditionFalls prevention in care homes
InterventionThe ACTiON FALLS Collaborative Events will take the form of workshops and include:
• Activities to encourage feedback on the use of the ACTiON FALLS programme
• Networking time for discussion between staff from different
• Training provided by NHS staff and researchers
• Collaborative engagement between care home staff, researchers, clinicians and policy makers together to develop implementation tools and techniques.
• Agreed actions for adaptations to the use of the ACTiON FALLS Programme to be taken forward by care home staff and research teams.

Feedback from ACTiON FALLS Collaborations (AFC) will inform the quality improvement cycle and help us to understand the barriers and facilitators to using the ACTiON FALLS Programme in day-to-day care within care homes.
Therefore, the ACTiON FALLS programme will be used within the participating care homes and adapted to assist with it's use in real time. Local NHS Falls Leads will be trained and deliver training to care home staff in the use of the ACTiON FALLS programme.

Data will be collected via:
• Observation and field notes made by researchers from AFC meetings.
• Interviews and focus groups of Care home staff in the homes which will take place within their workplace (care home), via VOIP e.g. Microsoft Teams or at the AFC events.
• NOMAD questionnaires completed by care home staff either electronically or via paper copies of the questionnaire sent to care homes.

The data from each of the four sites will be brought together to compare and contrast findings and to produce the final tool kit.

Participating care homes and staff will be enrolled in the study for 12 months. Within this time participating care home staff will be:
• Asked to take part in ACTiON FALLS training provided by the NHS falls leads within the care home, or remotely via VOIP e.g. Microsoft Teams.
• Encouraged to use the ACTiON FALLS programme within their day-to-day work with residents within the care home.
• Invited to up to three AFC events which will be held locally by the relevant ARC site team. The duration of these events will be decided locally based on care home staff availability as we acknowledge that this may vary depending on the current impact of Covid-19 on care home staffing.
• Invited to complete up to 2 NOMAD questionnaires. Sent out to care homes prior to each AFC event.
• Up to 12 members of care home staff from each ARC site will take part in interviews, these will be purposively selected based on their responses to the NOMAD questionnaire.
• Each care home will be asked to provide anonymised data regarding their number of falls each month. This is in line with data already provided by homes to regulatory authorities.

The methodology to this study has been derived following consultation and support from PPI and stakeholder groups including care home staff and residents. This was through interviews from the process evaluation within the previous FinCH RCT, stake holder forums held within the recent FinCH Implementation East Midlands study and PPI members within the co-applicants for the FinCH Imp National study. This involvement has lead to changes within the methodology including changing the name of the programme from GtACH which was poorly recognised and understood by the wider health and social care community to the more descriptive ACTiON FALLS programme. This has also led to the Quality Improvement Collaboratives renamed to AFCs as more acceptable to care home staff.
Intervention typeBehavioural
Primary outcome measure1. Understand the extent to which the collaborative approach has enabled effective implementation of the ACTiON FALLS programme across participating regions and homes. This will be achieved through measuring participation in collaborative events, reviewing the use of the ACTiON FALLs programme with residents, responses from the NOMAD instrument and using qualitative interviews
2. Collect monthly falls data from up to 1,770 residents (anonymous) using routinely collected data
3. Collect case studies at an individual resident, care home and regional level, of how the ACTiON FALLS programme has impacted on outcomes
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date01/10/2021
Overall study end date30/09/2024

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned Sample Size: 48; UK Sample Size: 48
Total final enrolment57
Participant inclusion criteriaCare Home inclusion criteria:
1. Long stay with old age and or dementia registration
2. Routinely record falls in resident personal records and on incident sheets

Care Home staff inclusion criteria:
3. Employed by a Care Home participating in FinCH Imp study
4. Employed in a caring role

Falls Leads inclusion criteria:
5. Participated in ACTiON FALLS trainer training
6. Provided ACTiON FALLS training in at least one participating care home
Participant exclusion criteriaCare Home exclusion criteria:
1. Homes exclusively providing care for those with learning difficulties or substance dependency
2. Homes with contracts under suspension with health or social providers, or that are currently subject to safeguarding investigations

Care Home staff exclusion criteria:
3. Not employed directly by the care home e.g., agency worker or student

Falls lead exclusion criteria:
4. None, provided inclusion criteria are met
Recruitment start date01/04/2022
Recruitment end date30/09/2022

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

University of Nottingham Medical School
Nottingham
NG7 2UH
United Kingdom
NIHR ARC East Midlands
University of Nottingham
Innovation Park Jubilee Campus
Triumph Road
Nottingham
NG7 2TU
United Kingdom
NIHR ARC South London
King’s College London
Institute of Psychiatry, Psychology & Neuroscience
Main Building, Room E2.19
De Crespigny Park
London
SE5 8AF
United Kingdom
NIHR ARC North East and North Cumbria
St Nicholas’ Hospital
Jubilee Road
Gosforth
Newcastle Upon Tyne
NE3 3XT
United Kingdom
NIHR ARC West Midlands
University of Warwick Office
Room B146, 1st Floor, Health Sciences
Warwick Medical School
University of Warwick
Coventry
CV4 7AJ
United Kingdom
NIHR CRN: East Midlands
Knighton Street Outpatients
1st Floor Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom
NHS South East London CCG
160 Tooley Street
London
SE1 2TZ
United Kingdom

Sponsor information

University of Nottingham
University/education

University Park
Nottingham
NG7 2RD
England
United Kingdom

Phone +44 1158467906
Email sponsor@nottingham.ac.uk
Website http://www.nottingham.ac.uk/
ROR logo "ROR" https://ror.org/01ee9ar58

Funders

Funder type

Government

NIHR Applied Research Collaboration Wessex

No information available

National Institute for Health Research
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 date30/06/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in publicly available repository
Publication and dissemination planWe plan to widely share the results from the study, within approximately 1 year of the study completion date (therefore, prior to October 2024). Dissemination activities will be aimed at relevant parties such as care home staff, owners and residents as well as commissioners and those with a responsibility for service planning and delivery. Dissemination activities will include:
• Peer reviewed journal articles
• Presentations at Care Home peer support networks
• Evidence summaries and infographics
• Video clips and social media posts
• Media coverage will be sought in the from of local newspapers, television and radio outlets.
• Requests will be sent to relevant agencies to feature the research project in their newsletters and websites.
• A study web page will feature on the ARC Wessex collaboration website.
IPD sharing planThe only quantitative datasets produced by the study will be the care home level falls rate data (number of falls per month and number of residents).
• repository name/weblink, - Virtual International Care Home Trials Archive (VICHTA), which will be a subsidiary of the Virtual Trials Archive (based at University of Glasgow)
• Type of data that will be shared –care home level data
• When the data will become available–after main results papers have been published.
• For how long - No fixed end date for how long data will be available
• By what access criteria the data will be shared including with whom - Data access managed by Virtual Trials Archive (VTA) and overseen by Trialist Steering Committee
• For what types of analyses, and by what mechanism,
• Whether consent from participants was obtained – there will be a care home agreement on place for their participation. Individual participants who take part in qualitative interviews will only produce qualitative data. For NoMAD questionnaires, consent is implied by the completing of the survey, so not formal consent form is completed.
• Comments on data anonymisation – all data will be fully anonymised by sender before it is transferred to VTA
• Any ethical or legal restrictions – all future analysis of pooled trial data must be performed on Virtual Trials Archive online platform – data remains on VTA server.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file version 1.0 11/01/2022 06/04/2022 No No
HRA research summary 28/06/2023 No No

Additional files

41444 PROTOCOL v1.0 11Jan22.pdf

Editorial Notes

17/03/2025: Total final enrolment was added and the intention to publish date was changed from 30/12/2024 to 30/06/2025.
11/09/2024: The following changes were made:
1. The overall study end date was changed from 30/09/2023 to 30/09/2024
2. The intention to publish date was changed from 30/09/2024 to 30/12/2024.
29/03/2022: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).