ISRCTN ISRCTN17206336
DOI https://doi.org/10.1186/ISRCTN17206336
ClinicalTrials.gov (NCT) Nil known
Clinical Trials Information System (CTIS) Nil known
Integrated Research Application System (IRAS) 336914
Central Portfolio Management System (CPMS) 59596
National Institute for Health and Care Research (NIHR) NIHR158676
Sponsor Yorkshire Ambulance Service NHS Trust
Funder National Institute for Health and Care Research
Submission date
14/11/2024
Registration date
10/02/2025
Last edited
20/11/2025
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Plain English summary of protocol
When a person is unable to get up from the floor for a long time after a fall, this is known as a “long lie”. Around one in three adults over 65 fall each year, and about one in five of these remain on the floor for over an hour. This can lead to serious problems such as dehydration, pressure sores, muscle damage, and distress. As ambulance response times increase, more people are being left on the floor for longer, which may worsen health outcomes.
Although there is a lot of research on preventing falls, much less is known about what happens to people who have been unable to get up after a fall or how best to support people while they wait for help. Current advice assumes ambulances arrive quickly and focuses on possible hip fractures, but most people who fall do not break a hip. Advice such as not moving or avoiding fluids may actually cause harm when someone is left on the floor for some time.
This study aims to understand what happens to people who cannot get up after a fall and how they can be better supported while waiting for help. We will:
1. Analyse linked NHS data (with all personal details removed) to find out who is affected, what happens after their fall, and how long people can be on the floor before harm increases (work package 1 [WP1]).
2. Estimate care costs by comparing people helped up quickly with those left for longer (WP2).
3. Review hospital notes for 200 patients to understand how long periods on the floor affect recovery (WP3).
4. Interview staff in ambulance, residential, and care home settings about current practice, advice given and possible future improvements (WP4 & 5).
5. Speak with patients who have been unable to get up after a fall and/ or their carers about their experiences and what could help in future (WP6).
6. Share findings in several national workshops to develop clear guidance for managing people after a fall (WP7).

Who can participate?
We are keen to speak with different groups of individuals working across the care pathway of those people who cannot get up after a fall, as well as from patients and carers. Specifically:
1. Home care workers (any location) and Care Home Managers (nursing and/ or residential) from organisations based in the following regions: East of England, East Midlands, North East, Wales and West Midlands [WP4b].
2. Professionals working in three Ambulance Service trust regions - Yorkshire, East Midlands, South West, involved in the patient pathway, i.e. Urgent Community Response (UCR) teams, frailty or falls services (community and acute settings), emergency department, other relevant roles who encounter people who cannot get up after a fall [WP5].
3. Individuals (and carers) that have recently experienced a fall and could not get up [WP6].

What does the study involve?
Staff working in health and/ or care organisations will be invited to take part in an interview (30-40 minutes), either by telephone or online, to share their experiences of managing people who cannot get up after a fall, the challenges involved, and any strategies used to mitigate harm while individuals await care.
Individuals (and carers) that have recently experienced a fall and could not get up will be invited to take part in two short interviews (30 minutes), either by telephone or online, to share their experience of the fall. The first interview will take place shortly after study registration, and the second 3-6 months later.
All data will be anonymised and handled confidentially. Participants will receive a £25 high-street shopping voucher as a thank you for each interview completed. CPD certificates will also be offered to health and care professionals.

What are the possible benefits and risks of participating?
There are no direct medical benefits to participants but the information the study results will help us to understand how guidance and care for people who fall and could not get up can be improved in the future. This should help ambulance services, care homes and also help future patients.

Where is the study run from?
The University of Sheffield and Yorkshire Ambulance Service NHS Trust (UK)

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?
Prof. Fiona Sampson, f.c.sampson@sheffield.ac.uk, longlies@sheffield.ac.uk

Contact information

Prof 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, Public

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 2981
Email m.kuczawski@sheffield.ac.uk

Study information

Primary study designObservational
Study designObservational mixed methods study
Secondary study designParallel design
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
Study objectivesCurrent objectives as of 12/11/2025:
1. To characterise the frequency and duration people remain on the floor following a fall in ambulance patients using data from one UK region held within the CUREd+ routine linked dataset
2. To understand the care trajectory, health outcomes, and health resource use of patients who fall and could not get up using the CUREd+ linked dataset
3. To understand the mechanisms by which people who fall and could not get up impacts care trajectories using hospital notes review for a subset of 200 patients identified from ambulance service data
4. To identify interventions used to mitigate the impact of remaining on the floor for a long time following a fall before arrival at hospital using a survey of ambulance services and social care providers
5. To understand how key stakeholders mitigate remaining on the floor for a long time following a fall using staff interviews;
6. To understand the impact of remaining on the floor for a long time following a fall on individuals using interviews with individuals and carers
7. To refine the definition of a ‘long lie’ that is likely to cause harm and identify actions to reduce their consequences for individuals

Previous objectives:
This 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)

1. 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

2. Approved 11/03/2025, School of Medicine and Population Health Research Ethics Committee (University of Sheffield, Western Bank Villa, 300-302 Western Bank, Sheffield, S10 2TN, United Kingdom; -; clinmed-pophealth-rec@sheffield.ac.uk), ref: 066991

3. Approved 28/02/2025, North East - Newcastle & North Tyneside 2 Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; -; newcastlenorthtyneside2.rec@hra.nhs.uk), ref: 25/NE/0005

4. Approved 16/07/2025, HRA & HCRW (-, -, -, United Kingdom; -; approvals@hra.nhs.uk), ref: 336914

5. Approved 06/06/2025, CAG (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; -; cag@hra.nhs.uk), ref: 25/CAG/0063

6. Approved 16/08/2024, School of Medicine and Population Health Research Ethics Committee (University of Sheffield, Western Bank Villa, 300-302 Western Bank, Sheffield, S10 2TN, United Kingdom; -; clinmed-pophealth-rec@sheffield.ac.uk), ref: 061049

7. Approved 28/03/2025, HRA & HCRW (-, -, -, United Kingdom; -; approvals@hra.nhs.uk), ref: 350537

8. Approved 16/08/2024, School of Medicine and Population Health Research Ethics Committee (University of Sheffield, Western Bank Villa, 300-302 Western Bank, Sheffield, S10 2TN, United Kingdom; -; clinmed-pophealth-rec@sheffield.ac.uk), ref: 061049

Health condition(s) or problem(s) studiedSpecialty: Trauma and Emergency Care, Primary sub-specialty: Pre-hospital; Health Category: Disputed Aetiology and Other
InterventionCurrent methodology as of 12/11/2025:
This observational mixed-methods study will investigate the experiences and outcomes of adults who have fallen and were unable to get up from the floor for an extended period – a ‘long lie’. Participants will be identified through linked ambulance, emergency department, and hospital records, with all personal information removed prior to analysis. Quantitative analyses will describe who is affected, the duration spent on the floor, associated health complications, and patterns of healthcare use over the following 12 months. Health and social care costs will also be estimated, and detailed hospital record reviews will be conducted for a subset of 200 patients to examine clinical outcomes.

To understand current practice, interviews will be undertaken with professionals from ambulance, hospital, and residential or care home settings to explore how people are supported after a fall and while waiting for help. A further group of interviews will be conducted with people who have experienced being unable to get up after a fall, and with their relatives or carers, to explore personal experiences and the impact on daily life.

Findings from both the quantitative and qualitative components will be discussed in a national workshop with key stakeholders from health and social care services. This will inform the development of clear, evidence-based guidance to support people who have fallen and are awaiting assistance.

Previous methodology:
The 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 measure(s)

Current primary outcome measures as of 12/11/2025:
1. Factors associated with length of lie (source: YAS automated free-text search/CUREd+ dataset linkage):
1.1. Length of lie in minutes (continuous)
2. Association between length of lie and patient care pathway outcomes (source: CUREd+ dataset linkage):
2.1. Ambulance conveyance (vs see and treat) at attendance (conveyance), 30 days and 6 months post-fall (mortality)
3. Operationalising a harmful length of lie (source: CUREd+ dataset linkage):
3.1. Standardised rate ratios (ratio of observed/expected events). Determined by analysis of outcomes (e.g., mortality) across intervals of lie duration.
4. Qualitative outcome measures (source: interviews and focus groups):
4.1. Stakeholder management and mitigation of long lies; patient/carer perspective, psychological impact, and advice needs.

Previous primary outcome measure:
The 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

Key secondary outcome measure(s)

Current secondary outcome measures as of 12/11/2025:
1. Factors associated with length of lie (source: YAS automated free-text search/CUREd+ dataset linkage):
1.1. Length of lie in minutes - 'short' vs 'long' lie (categorical with pre-defined cutoffs)
2. Association between length of lie and patient care pathway outcomes (source: CUREd+ dataset linkage):
2.1. Incidence of acute admission to hospital (binary)
2.2. Length of stay of the admission (continuous)
2.3. Number of investigations at ED (count)
2.4. Number of treatments received at ED (count)
2.5. Level of urgency/acuity of the ED attendance (categorical)
2.6. Discharge to care home or 'step down' or intermediate care (categorical)
2.7. Number of and time to first readmission within 12 months (count/time-to-event)
2.8. Number of and time to first unplanned ED attendance within 12 months (count/time-to-event)
2.9. Number of and time to first NHS 111 call within 12 months (count/time-to-event)
2.10. Number of and time to first ambulance callout within 12 months (count/time-to-event)
2.11. Number of and time to first outpatient contact within 12 months (count/time-to-event)
2.12. Corresponding measures of acuity/urgency for each healthcare re-contact

Previous secondary outcome measures:
There are no secondary outcome measures

Completion date30/06/2026

Eligibility

Participant type(s)Patient
Age groupMixed
Lower age limit18 Years
Upper age limit100 Years
SexAll
Target sample size at registration473
Key inclusion criteriaCurrent inclusion criteria as of 12/11/2025:
WP3: Patients must have fallen, been unable to get up off the floor, and consequently called 999 for an ambulance. They must also have been transported (conveyed) to one of the four participating study hospitals within the Yorkshire and Humber region.

WP4a: UK NHS 999 Emergency Operations Centre ambulance service clinical leads.

WP4b: Residential and nursing home managers, and Home care Workers in the UK.

WP4c: Those working in residential and nursing homes, providing home care support, and in other providers of social care.

WP5: Health professionals involved in the management of individuals that are unable to get up from the floor for a long time after a fall, working in three ambulance service areas – South West, East Midlands and Yorkshire and Humber. Seeking individuals in a variety of organisations and roles such as Urgent Community Response (UCR); Frailty or falls services (community and acute settings), emergency departments, other relevant roles.

WP6: Individuals (and their carers) who have fallen and been unable to get up off the floor for a long period of time, and help was contacted.

Previous inclusion criteria:
WP4 - 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.
Key exclusion criteriaCurrent exclusion criteria as of 12/11/2025:
WP3: Registration with NHS Data Opt-out, or if they have already been approached to participate in the study.

WP5: Health professionals working in the healthcare field who are not directly involved in the management of this patient cohort and does not work within the three specific geographical boundaries.

Previous exclusion criteria:
Not meeting the participant inclusion criteria
Date of first enrolment24/04/2025
Date of final enrolment30/05/2026

Locations

Countries of recruitment

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

Study participating centres

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

Results and Publications

Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in publicly available repository
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
Protocol file version 1.5 20/11/2025 No No
Study website 11/11/2025 11/11/2025 No Yes

Additional files

46397_Protocol_v1.2_April 2024.pdf
Protocol file
ISRCTN17206336_PROTOCOL_V1.5.pdf
Protocol file

Editorial Notes

20/11/2025: Protocol uploaded, ethics approval details added.
12/11/2025: The following changes were made to the study record:
1. The plain English summary of protocol, contact details, study objectives, methodology, primary/secondary outcome measures, and inclusion/exclusion criteria were updated.
2. The date of first enrolment was changed from 01/01/2025 to 24/04/2025.
3. The date of last enrolment was changed from 31/12/2025 to 30/05/2026.
05/03/2025: Contact details updated.
14/11/2024: Study's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).