ISRCTN ISRCTN17206336
DOI https://doi.org/10.1186/ISRCTN17206336
IRAS number 336914
Secondary identifying numbers CPMS 59596, NIHR158676
Submission date
14/11/2024
Registration date
10/02/2025
Last edited
05/03/2025
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Not Specified
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Background and study aims
When someone falls and can't get up from the floor for over an hour this is called a long lie. In the over-65 age group, 1 in 3 people will fall at least once a year and around 20% of these falls will result in a long lie. A long lie may lead to other problems, such as dehydration, pressure injuries and emotional distress. More demand for ambulances means that people who fall may wait longer for help and that more people may experience a long lie. Current advice to not give fluids or move people who have fallen is mainly focused on people who may have a hip fracture and need surgery. It also assumes an ambulance will arrive quickly. Most people who fall do not have a fractured hip and this advice may be harmful.

Who can participate?
This study focuses on WP 4 and 5 involving staff in care or nursing homes, ambulance staff and staff in hospitals who care for patients who have had a fall and can't get up from the floor.

What does the study involve?
WP4. This package will understand how health and social care organisations currently manage patients after a fall to reduce the harm from a long lie using a telephone survey of ambulance services and a survey of residential or care home staff.
WP5. This package will speak to people who advise patients (ambulance clinicians, hospital staff, social and residential home staff) when they are awaiting help to understand what advice they currently give people when they have fallen, and what they feel could be improved.

What are the possible benefits and risks of participating?
Whilst we do not feel that the study poses any significant ethical concerns, there are several areas that we need to pay attention to in relation to data, staff and patient confidentiality and patient autonomy. The main ethical issues are informed consent for interviews with staff and patients, consent to access patient records and confidentiality of data.

Where is the study run from?
Yorkshire Ambulance Service NHS Trust, Mid Yorkshire Teaching Hospitals Trust and the University of Sheffield

When is the study starting and how long is it expected to run for?
April 2024 to June 2026.

Who is funding the study?
The National Institute for Health and Care Research (NIHR)

Who is the main contact?
Dr Fiona Sampson, f.c.sampson@sheffield.ac.uk

Study website

Contact information

Dr Fiona Sampson
Scientific, Principal Investigator

Sheffield Centre for Health and Related Research (ScHARR), University of Sheffield, Regent Court, 30 Regent Street
Sheffield
S1 4DA
United Kingdom

ORCiD logoORCID ID 0000-0003-2321-0302
Phone +44 (0)114 222 5454
Email f.c.sampson@sheffield.ac.uk
Dr Joanne Coster
Public, Scientific

Sheffield Centre for Health and Related Research (ScHARR), University of Sheffield, Regent Court, 30 Regent Street
Sheffield
S1 4DA
United Kingdom

Phone +44 (0)114 222 5454
Email j.e.coster@sheffield.ac.uk
Mrs Maxine Kuczawski
Scientific

Centre for Urgent and Emergency Care Research (CURE)
School of Medicine and Population Health (ScHARR)
University of Sheffield
30 Regent Street
Sheffield
S1 4DA
United Kingdom

Phone +44 (0)114 222 2981
Email m.kuczawski@sheffield.ac.uk

Study information

Study designObservational mixed methods study
Primary study designObservational
Secondary study designParallel design
Study setting(s)Care home, Home, Hospital, Internet/virtual, Medical and other records, Paramedicine, Telephone
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleMixed methods study to understand the scale, impact and care trajectory for patients who have a long lie after a fall
Study acronymLong lies
Study hypothesisThis study aims to understand what happens when people have a long lie after a fall and how people can be helped while waiting for an ambulance.

This is a mixed methods study incorporating 7 linked work packages over 27 months (April 2024-June 2026). NHS Ethics, HRA, CAG, and CUREd+ approvals will take place in months 0-6. As part of the approvals process, preliminary drafts of surveys (WP4) and interview materials (WP5, WP6) will be developed in collaboration with PPI and stakeholders during these months. These will be updated following outcomes and feedback from the telephone survey with residential care/ nursing homes in WP4. The overall design is an observational mixed methods study, following a parallel design, with data from six interrelated work packages being integrated before the development of guidance with key stakeholders (WP7) (O’Cathain 2010). The research addresses a recognised research gap and is problem-driven rather than theory-driven, arising from a long-standing service-led need for information about the management of patients with long-lie that has been exacerbated by contextual factors such as increasing ambulance service pressures and resulting ambulance delays.
Ethics approval(s)

Approved 16/08/2024, Sheffield Centre for Health and Related Research (ScHARR) Research Ethics Committee (University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, United Kingdom; +44 114 222 1443; l.v.unwin@sheffield.ac.uk), ref: 061049

ConditionSpecialty: Trauma and Emergency Care, Primary sub-specialty: Pre-hospital; Health Category: Disputed Aetiology and Other
InterventionThe team is conducting a mixed methods study comprising seven interrelated work packages (WP1-WP7). A brief overview of the entire project is provided below. Ethics approval from the University of Sheffield (UOS) has been obtained for WP4 and WP5, but Health Research Authority (HRA) approval is also required. Additionally, a subsequent HRA and NHS ethics application will be submitted for WP3 and WP6.

WP1: This work package aims to understand the characteristics and care trajectory of ambulance service patients who have been unable to get up after a fall. Using the CUREd+ dataset, which includes routine emergency care data from the Yorkshire & Humber region, the team will explore the demographic and clinical characteristics of patients experiencing a long lie and analyse trends in the frequency and duration of long lies. The dataset will also be used to understand the care trajectory of these patients.

WP2: This work package focuses on understanding the resource use of ambulance service patients after their fall. The CUREd+ dataset and NHS routine costs will be utilised to model the healthcare resource use of patients unable to get up following a fall and to understand the economic impact of long lies.

WP3: This work package aims to understand the mechanisms for the impact of long lies by reviewing patient notes. A detailed review of all patient records for three months following a fall will be conducted for a subset of 200 patients conveyed to hospitals within the Yorkshire and Humber region. The data will be used to explore how a long lie impacts the patient care trajectory and key health outcomes. Fifty patients will be identified at each of four hospitals with an Emergency Department within the region. Expressions of interest will be invited from all eligible hospitals. Research nurses will seek consent from patients within two weeks of their initial hospital attendance and request permission to access their notes from the initial ambulance contact up until 90 days after their fall. Translators will be available for patients who require them to ensure inclusivity. CAG approval will be included in the future NHS ethics and HRA application for patients who lack capacity, are seriously ill, or die during the care episode.

WP4: This work package aims to identify how health and social care organisations mitigate long lies. Existing interventions used in health and social care settings will be identified, and strategies used by key stakeholders to manage patients at risk of a long lie will be understood. This will be done through three sub-packages:

WP4a: A structured survey of all UK NHS 999 Emergency Operations Centre ambulance service clinical leads to understand current interventions, local guidance, and initiatives for managing long lies.
WP4b: A structured survey of residential and nursing home managers in the Yorkshire area to understand initiatives used within care facilities to manage patients while awaiting ambulance services.
WP4c: An online survey of care-sheltered housing and social care providers, disseminated via social media and Local Authority Link networks (LARks), to provide a descriptive analysis of interventions from ambulance services and care providers.
WP5: This work package aims to understand how key stakeholders mitigate and manage long lies. Semi-structured telephone or online interviews will be conducted with 22-26 key stakeholders across three ambulance service areas. The National Ambulance Research Group (NARSG) will be engaged to identify sites expressing interest in participating.

WP6: This work package explores the impact of long lies on patients and carers. Interviews will be conducted with a diverse group of 18-24 patients who have experienced a long lie after a fall and their carers to understand the impact on issues important to patients. Recruitment will be done through various approaches, including patients from WP3, existing networks and registries, and patient groups. Recruitment materials have been developed with the PPI group, and efforts will be made to include traditionally minoritised groups. Translation services will be provided as needed, and participants will be offered £25 Love2Shop vouchers as a thank-you for participating. HRA approvals and NHS ethics for this work package will be recruited later.

WP7: This work package focuses on making recommendations for service policy to reduce risk to patients. Findings from multiple workstreams will be integrated. The team will collaborate with diverse key stakeholders across the identified care trajectory to co-produce guidance for hospitals, ambulance services, and patients/carers. Additionally, recommendations for service policy will be developed to reduce risk to patients and avoid unnecessary healthcare resource use.
Intervention typeOther
Primary outcome measureThe identification and evaluation of effective interventions and strategies used by healthcare and social care providers to manage and mitigate the impact of long lies for patients measured using data collected from surveys, interviews, and data analysis from multiple work packages (WP4a, WP4b, WP4c, and WP5), throughout the study, with final evaluation upon completion of all work packages
Secondary outcome measuresThere are no secondary outcome measures.
Overall study start date01/04/2024
Overall study end date30/06/2026

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 473; UK Sample Size: 473
Participant inclusion criteriaWP4 - UK NHS 999 Emergency Operations Centre ambulance service clinical leads (n=13)

WP4b) residential and nursing home managers in the Yorkshire area (using the 18+ Wakefield Research Hub networked research-active residential homes)

WP4c) UK-wide care and residential home managers

WP5 n = 22-26. Key stakeholders across 3 ambulance service areas - a variety of roles in the ambulance service including frontline clinicians and 999 call handlers. Hospitals within the participating ambulance will identify staff that are involved throughout the process of care such as ED, frailty and acute medicine departments (dependent upon the findings from WP1). Residential and care home staff in the participating ambulance service areas.
Participant exclusion criteriaNot meeting the participant inclusion criteria
Recruitment start date01/01/2025
Recruitment end date31/12/2025

Locations

Countries of recruitment

  • England
  • Northern Ireland
  • Scotland
  • United Kingdom
  • Wales

Study participating centres

North East Ambulance Service NHS Ft
Bernicia House
Goldcrest Way
Newcastle upon Tyne
NE15 8NY
United Kingdom
Yorkshire Ambulance Service NHS Trust
Springhill
2 Brindley Way
Wakefield 41 Industrial Estate
Wakefield
WF2 0XQ
United Kingdom
North West Ambulance Service NHSTrust
Ladybridge Hall
399 Chorley New Road
Bolton
BL1 5DD
United Kingdom
West Midlands Ambulance Service University NHS Foundation Trust
Millennium Point
Waterfront Business Park
Dudley Road
Brierley Hill
DY5 1LX
United Kingdom
East Midlands Ambulance Service Trust Hq
1 Horizon PLACE
Mellors Way
Nottingham Business Park
Nottingham
NG8 6PY
United Kingdom
South Western Ambulance Service NHS Foundation Trust
Abbey Court
Eagle Way
Sowton Industrial Estate
Exeter
EX2 7HY
United Kingdom
South Central Ambulance Service NHS Foundation Trust
7-8 Talisman Business Centre
Talisman Road
Bicester
OX26 6HR
United Kingdom
South East Coast Ambulance Service NHS Foundation Trust
Trust Headquarters
Nexus House
4 Gatwick Road
Crawley
RH10 9BG
United Kingdom
London Ambulance Service NHS Trust
220 Waterloo Road
London
SE1 8SD
United Kingdom
East of England Ambulance Service NHS Trust
Unit 3
Whiting Way
Melbourn
Royston
SG8 6NA
United Kingdom
Welsh Ambulance Services NHS Trust
Unit 7
Ffordd Richard Davies
St Asaph Business Park
St. Asaph
LL17 0LJ
United Kingdom
Scottish Ambulance Service
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB
United Kingdom
Ni Ambulance Service Health and Social Care Trust
Knockbracken Healthcare Park
Saintfield Road
Belfast
BT8 8SG
United Kingdom
Leeds Community Healthcare NHS Trust
3 White Rose Office Park
Millshaw Park Lane
Leeds
LS11 0DL
United Kingdom
Mid Yorkshire Teaching NHS Trust
Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG
United Kingdom

Sponsor information

Yorkshire Ambulance Service NHS Trust
Hospital/treatment centre

Springhill, 2 Brindley Way, 41 Industrial Estate
Wakefield
WF2 0XQ
England
United Kingdom

Phone +44 (0)330 678 4100
Email Yas.research@nhs.net
Website https://www.yas.nhs.uk/
ROR logo "ROR" https://ror.org/01sawky49

Funders

Funder type

Government

National Institute for Health and Care 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 date30/06/2026
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in publicly available repository
Publication and dissemination planDissemination will include active methods (e.g. workshop), infographic dissemination and written peer-reviewed publications. The project advisory group will advise on dissemination strategies. The PPI group will connect with the research team to ensure that engagement and dissemination strongly represent the voices and interests of patients at risk of falling/long lie and their carers. Progress and findings will be advertised on the project website (hosted at UoS) and shared by project-specific social media accounts. We will write up findings for WP1-3, WP4, WP5 and WP6 as Open Access threaded publications as well as a mixed methods paper of overall findings, incorporating WP7 recommendations. High impact academic journals we will target include Age & Ageing, BMC Geriatrics, BMJ Open and Annals of Emergency Medicine. We have set up a study website and will disseminate via social media accounts to update on study progress and dissemination activities. Findings will be presented at UK & international conferences (e.g. EMS2025, 999EMSResearch Forum, HSRUK). We will work with key professional organisations (including National Ambulance Service Medical Directors (NASMeD) and other AACE sub-groups, Royal College Emergency Medicine, British Geriatric Society, College of Paramedics, NHS Pathways/AMPDS, National Care Forum) to disseminate summaries of the research findings, particularly recommendations and action plans generated from workshops in WP7 in order to maximise impact on policy. We will work with our PPI group to guide wider dissemination of lay research summaries, and will co-produce a publication with PPI about PPI findings, as well as deliver a PPI co-produced 2-3 minute long narrated animation and PPI co-produced easy-read infographic.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from the contact details listed in the publicly available data access and management plan: Data Management and Access Plan (https://netscc-webapps.soton.ac.uk/damps/damps-document.phtml?id=NIHR158676). The Data Management and Access Plan outlines which data are not available upon request due to the ethical restrictions and approvals in place to protect the special category health data included in WP1, 2 and 3.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file version 1.2 02/04/2024 28/11/2024 No No

Additional files

46397_Protocol_v1.2_April 2024.pdf

Editorial Notes

05/03/2025: Contact details updated.
14/11/2024: Study's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).