Do Safe and Well Visits Delivered by the Fire and Rescue Service Reduce Falls and Improve Quality of Life Among Older People? A Randomised Controlled Trial
Phase: NA
Conditions: Accidental Fall, Quality of Life, Aged
Sponsor: Caroline Fairhurst

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TRIAL PROTOCOL 
Version   6.0      29th July 2022 
  
 
 
 
Full title:  Do Safe and Well Visits delivered by the Fire and Rescue Service reduce falls and 
improve quality of life among older people? A randomised controlled trial (FIREFLI) 
 
 
ClinicalTrials.gov Identifier: NCT 04717258 
REC Reference:  21/WM/0050 
Sponsor: The University of York  
Funder: This study is funded by the National Institute for Health Research (NIHR) Public 
Health Research (PHR) Programme (project reference 128341 ). The views expressed are 
those of the author(s) and not necessarily those of the NIHR or the Department of 
Health and Social Care. 
 
Authorised by  
Name: Mrs Sarah Cockayne  
Role: Chief Investigator  
 
Signature:                                                         Date: 29.07.2022 
 
 
                           

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1. Contents 
1. 
Contents ............................................................................................................................................... 2 
2. 
Trial contacts ........................................................................................................................................ 6 
3. 
Trial summary ....................................................................................................................................... 9 
3.1  
Trial summary table ..................................................................................................... 9 
3.2 
Study flow chart of participants through the FIREFLI study ...................................... 11 
3.3 
Participant assessment schedule .............................................................................. 12 
3.4  
Plain English summary ............................................................................................... 13 
4. 
Background ......................................................................................................................................... 14 
4.1 
Safe and Well Visits ................................................................................................... 14 
4.2   Fire and falls ............................................................................................................... 15 
4.3  
Smoking and risk of fire ............................................................................................. 16 
4.5 Cold homes and winter warmth .................................................................................... 19 
4.6  
Aim of the research ................................................................................................... 19 
4.6.1 
Primary aim .......................................................................................................................... 20 
4.6.2 
Secondary aims .................................................................................................................... 20 
5 
Study design ....................................................................................................................................... 20 
5.1 
Study design ............................................................................................................... 20 
5.2 
Identification of sites ................................................................................................. 20 
5.3  
Identification of participants to receive an invitation mail out ................................ 20 
5.3.1  
Opting out of the  mail out .................................................................................................. 24 
5.3.2 
Advertising for participants ................................................................................................. 25 
5.4  
Declining participation in the study .......................................................................... 25 
5.5  
People who wish to take part in the study ................................................................ 26 
5.5.1 
Assessment of eligibility ...................................................................................................... 26 
5.5.2 
Informed consent and completion of the consent form ..................................................... 27 
5.5.3 
Informed consent and completion of the consent form in participants lacking capacity .. 28 
5.5.4 
Completion of the baseline questionnaire .......................................................................... 31 
6. 
Eligibility criteria for the FIREFLI trial ................................................................................................. 31 
6.1  
Assessment of eligibility ............................................................................................ 32 
6.1.1 
Inclusion criteria .................................................................................................................. 32 
6.1.2 
Exclusion criteria .................................................................................................................. 32 

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6.2 
 Primary outcome ...................................................................................................... 33 
6.3 
Data collection for the primary outcome for the trial .............................................. 33 
6.3.1     Falls data ................................................................................................................................ 33 
6.3.2 
  Health-related quality of life (EQ-5D-5L) data ................................................................... 34 
6.4 
Secondary outcomes and other important data ....................................................... 34 
6.5 
Data collection for secondary outcomes ................................................................... 36 
6.6   Participant withdrawal .............................................................................................. 36 
6.7  
Randomisation ........................................................................................................... 36 
6.8  
Blinding ...................................................................................................................... 37 
6.9 
Usual supportive care group ..................................................................................... 37 
6.10  Intervention group..................................................................................................... 38 
6.10.1 Fire safety issues ...................................................................................................................... 39 
6.10.2 
Falls prevention ................................................................................................................... 40 
6.10.3 Smoking cessation ................................................................................................................... 40 
6.10.4 Social isolation ......................................................................................................................... 40 
6.10.5 Cold homes and housing conditions ....................................................................................... 40 
6.11  Training for clinicians delivering the trial treatment ................................................. 41 
7. 
 Data collection ................................................................................................................................... 41 
7.1   Quantitative data collection ...................................................................................... 41 
7.2  
Mixed methods process evaluation .......................................................................... 42 
7.2.1  
Implementation, fidelity and acceptability of interventions: .............................................. 42 
7.2.2  
Qualitative analysis .............................................................................................................. 45 
7.3 
Study within a Trial (SWAT) ....................................................................................... 45 
8  
Statistical considerations .................................................................................................................... 46 
8.1 
Sample size ................................................................................................................ 46 
8.2 
Statistical analysis for the main FIREFLI trial ............................................................. 47 
8.3 
Primary outcome for the main FIREFLI trial .............................................................. 48 
8.4 
Subgroup analyses ..................................................................................................... 49 
8.5  
Sensitivity analyses .................................................................................................... 49 
8.6 
Missing data ............................................................................................................... 49 
8.7 
Intervention adherence ............................................................................................. 49 
8.8 
Secondary outcomes for the main FIREFLI trial ........................................................ 50 
8.8.1 
Proportion of participants falling, experiencing a fracture or fear of falling ...................... 50 
8.8.2 
Time to fall ........................................................................................................................... 50 

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8.8.3 
 Fear of falling, loneliness and fire risk score ....................................................................... 51 
8.8.4  
Flu jab, smoking outcomes .................................................................................................. 51 
8.8 
Economic analysis ...................................................................................................... 51 
8.9 
Definition of the end of the trial ............................................................................... 53 
9. Adverse Event Reporting ....................................................................................................................... 53 
9.1  
Adverse Events .......................................................................................................... 53 
9.2  
Definition of Serious Adverse Events ........................................................................ 54 
9.3  
Expected Adverse Events and expected side effects ................................................ 54 
9.4  
Definition of a related adverse event ........................................................................ 55 
9.5 
Reporting period ........................................................................................................ 55 
10.  Trial monitoring .................................................................................................................................. 55 
10.1  Site monitoring .......................................................................................................... 55 
10.2  Standard Operating Procedures ............................................................................... 56 
11.  Public Involvement and Engagement (PIE) ........................................................................................ 56 
12.  Ethical issues ....................................................................................................................................... 56 
12.1  Protocol amendments ............................................................................................... 57 
12.2  Legal bases of processing data .................................................................................. 57 
12.3 Anticipated risks and benefits ................................................................................... 57 
12.4  Informing participants of anticipated risks and benefits .......................................... 57 
12.5 Retention of study documentation ........................................................................... 58 
12.6  Access to data ............................................................................................................ 59 
12.7  Confidentiality ........................................................................................................... 59 
12.8 Consent ...................................................................................................................... 59 
12.8.1 
Consent to the main trial ..................................................................................................... 59 
12.8.2 
Consent to the qualitative study ......................................................................................... 60 
12.8.3 Consent to the SWAT .............................................................................................................. 60 
12.8.4 
Consent for the observation ................................................................................................ 60 
13.  Oversight ............................................................................................................................................ 60 
13.1 Sponsorship ............................................................................................................... 60 
13.2  Indemnity ................................................................................................................... 60 
13.3 Funding acknowledgement ....................................................................................... 61 
13.4  Independent Trial Steering and Data Monitoring and Ethics Committee................. 61 
13.5  Trial Management Group (TMG) ............................................................................... 61 
13.6  Disclaimer .................................................................................................................. 62 

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14. Publication policy ............................................................................................................................... 62 
15. Plan of investigation and timetable ................................................................................................... 63 
16. Declaration of interests ...................................................................................................................... 63 
17.  List of abbreviations .......................................................................................................................... 64 
18. Table of protocol changes .................................................................................................................. 65 
19. References .......................................................................................................................................... 66 
20. Appendix 1 .......................................................................................................................................... 69 
20.1  Recruitment SWAT .................................................................................................... 69 
Inclusion criteria ................................................................................................................................. 69 
Outcome measure .............................................................................................................................. 70 
Secondary outcomes include: ............................................................................................................ 70 
Sample size ......................................................................................................................................... 70 
Statistical analysis ............................................................................................................................... 70 
20.2 Retention SWAT ......................................................................................................... 70 
Inclusion criteria ................................................................................................................................. 71 
Exclusion criteria................................................................................................................................. 71 
Outcome measures ............................................................................................................................ 71 
Sample size ......................................................................................................................................... 71 
Statistical analysis ............................................................................................................................... 72 
 
 
 

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2. 
Trial contacts  
 
Chief Investigator  
Mrs Sarah Cockayne  
 
University of York, Dpt Health Sciences, York Trials Unit, 
ARRC Building, Lower Ground Floor, York YO10 5DD 
Email: sarah.cockayne@york.ac.uk 
Tel: 01904 321736 
 
 
 
 
Co-applicants 
 
 
Professor Joy Adamson  
University of York, Dpt Health Sciences, York Trials Unit, 
ARRC Building, Lower Ground Floor, York YO10 5DD 
Email: joy.adamson@york.ac.uk  
 
 
Mrs Shelley Crossland 
 
Hinckley and Bosworth CMHT, Older People, Hynca 
Lodge, Tudor Road, Hinckley, LE10 0EW 
Email: shelley.crossland@leicspart.nhs.uk 
 
Dr Rachel Cunningham-
Burley (Trial Coordinator) 
 
University of York, Dpt Health Sciences, York Trials Unit, 
ARRC Building, Lower Ground Floor, York YO10 5DD 
Email: rachel.cunningham-burley@york.ac.uk  
Tel: 01904 328088 
 
Professor Avril 
Drummond 
 
The University of Nottingham, Queen’s Medical Centre, 
Nottingham, NG7 2UH 
Email: avril.drummond@nottingham.ac.uk 
 
Mr Steve Duffield  
 
Public Safety Central, Humberside Fire and Rescue 
Service. 
Email: sduffield@humbersidefire.gov.uk  
 
Ms Caroline Fairhurst  
(Trial Statistician) 
 
University of York, Dpt Health Sciences, York Trials Unit, 
ARRC Building, Lower Ground Floor, York YO10 5DD 
Email: caroline.fairhurst@york.ac.uk 
 

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Tel: 01904 321513 
Professor Catherine 
Hewitt 
 
University of York, Dpt Health Sciences, York Trials Unit, 
ARRC Building, Lower Ground Floor, York, YO10 5DD 
Email: catherine.hewitt@york.ac.uk 
Tel: 01904 3211374 
 
Ms Jo Mann 
Public Safety Central, Humberside Fire and Rescue 
Service.  
Email: jmann@humbersidefire.gov.uk 
 
Associate Professor 
Alison Pighills 
 
Queensland Health / James Cook University, Education 
and Research Centre (K Block), Mackay Base Hospital, P.O 
Box 5580, Mackay Mail Centre, Mackay, Queensland 4741 
Email: alison.pighills@health.qld.gov.au 
 
 
Mrs Sarah Ronaldson 
(Health economist) 
University of York, Dpt Health Sciences, York Trials Unit, 
ARRC Building, Lower Ground Floor, York, YO10 5DD 
Email: sarah.ronaldson@york.ac.uk 
Tel: 01904 321871 
 
 
Dr Arabella Scantlebury 
 
University of York, Dpt Health Sciences, York Trials Unit, 
ARRC Building, Lower Ground Floor, York YO10 5DD  
Email: arabella.scantlebury@york.ac.uk  
 
Mr 
Richard 
Stanford-
Beale 
Kent Fire & Rescue Service, The Godlands, Straw Mill Hill, 
Tovil, Maidstone, Kent, ME15 6XB 
Email: richard.stanford-beale@kent.fire-uk.org 
 
Professor David 
Torgerson 
 
University of York, Dpt Health Sciences, York Trials Unit, 
ARRC Building, Lower Ground Floor, York YO10 5DD  
Email: david.torgerson@york.ac.uk  
Tel: 01904 321340 
 

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Ms Sarah Wilkinson 
Public Safety Central.  Humberside Fire and Rescue 
Service. 
 
 
Data managers 
 
Mr Matthew Bailey 
University of York, Dpt Health Sciences, York Trials   Unit, 
ARRC Building, Lower Ground Floor, York YO10 5DD 
Email: matthew.bailey@york.ac.uk        
Tel: 01904 321364 
 
 
 
 
Mrs Val Wadsworth 
 
 
 
 
University of York, Dpt Health Sciences, York Trials Unit 
ARRC Building, Lower Ground Floor, York YO10 5DD 
Email: val.wadsworth@york.ac.uk   
Tel: 01904 321363 
 
  
 
Sponsor representative  
 
Dr Michael Barber  
University of York, Research & Enterprise Directorate, 
RCH/135, Ron Cooke Hub, York YO10 5GE 
 
Email: michael.barber@york.ac.uk  
 
 
 
 
 
 

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3. 
Trial summary 
3.1  
Trial summary table  
 
Long title 
Do Safe and Well Visits (SWV) delivered by the Fire and Rescue service 
(FRS) reduce falls and improve quality of life among older people? A 
randomised controlled trial. 
 
Acronym  
FIREFLI  
 
Study design 
A large pragmatic, individually randomised, controlled trial with 
embedded economic and qualitative evaluations.   
 
Setting 
Participants’ homes. 
 
Target population  
1156 community dwelling men and women aged 65 years and over.  
Participants will be recruited from databases held by Humberside and 
Kent FRSs.   
 
Control  
Usual care from healthcare professionals; falls prevention leaflet; 
SWV by the FRS (either a firefighter, day duty safety advocate or Safe 
and Well Officer) offered 12 months post-randomisation.  
 
Intervention  
Usual care from healthcare professionals; falls prevention leaflet; 
SWV offered by the FRS (either a firefighter, day duty safety advocate 
or Safe and Well Officer) approximately three weeks post-
randomisation.  
 
Primary outcome 
There are two primary outcomes: 
1. The number of self-reported falls per participant over the 12 
months from randomisation 
2. Health-related quality of life measured by the EQ-5D-5L 
(EuroQol 5 Dimensions, 5 level version) over the 12 months 
from randomisation. 
 
Secondary outcomes 
 Time to first fall and between subsequent falls 
 Proportion of participants reporting at least one fall and 
multiple falls (two or more falls) 
 Fear of falling 
 Loneliness (UCLA 3-item) 
 Fall related injuries and costs 
 Fire risk taking behaviours 
 Uptake of flu jab 
 Smoking status of residents within the property; smoking 
inside the property; smoking in bed; referral to NHS stop 
smoking services  
 Participant-reported fire within the property that the FRS 
attended 

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 Participant-reported  fire within the property that the FRS did 
not attend  
 FRS-reported attendances to participants’ homes for fire 
related incidents.    
 
Estimated recruitment 
period  
September 2021 to September 2022 dependent on COVID-19  
Duration per patient 
13 to 24 months approximately  
 
Estimated total trial 
duration (subject to 
approval from PHR) 
50 months  
February 2020 to March 2024 
(Subject to delays due to COVID-19 pandemic) 
 
Number of participants 
1156 
 
Number of trial sites  
Two (Geographical areas covered by Humberside and Kent FRSs). 
 
Inclusion criteria  
  
 Men and women aged 65 years and over (Humberside) or 70 
years and over (Kent) 
 Community dwelling 
 Willing to receive a SWV from the FRS  
 
Exclusion criteria  
 
 Living in a residential or nursing home 
 Bed bound 
 Unable to give informed consent to take part in the study and 
living alone  
 Had an occupational therapist (OT) home visit within the past 
12 months 
 Received a SWV from the FRS in the past three years  
 Have been referred to the FRS as an urgent referral 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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3.2 
 Study flow chart of participants through the FIREFLI study  
 
 
 
          
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Intervention Group 
N = 578 
Control Group 
N =578 
One home visit lasting approximately 
60 minutes by the FRS using the FRS 
SWV checklist. Recommendations and 
referrals made. 
Age UK falls prevention leaflet. 
Usual care  
 
Age UK falls prevention 
leaflet. 
 
Potential participants identified via FRS databases; mail out of study invitation packs (invitation letter, 
information sheet, consent form, screening form and pre-paid envelope). 
1156 participants who return a baseline questionnaire and one falls calendar within the past three months 
are randomised.  
Participants interested in taking part return screening form and consent form to the York Trials Unit (YTU). 
YTU assess eligibility.  Eligible participants are sent a baseline questionnaire, falls calendars and falls 
prevention leaflet. 
Qualitative interviews with service leads to discuss current provision (n=5). 
Newsletter sent to participants at 3 and 7 months, and 11.5 monthsby YTU 
4, 8 and 12 month follow-up questionnaire sent to participants by YTU.  
Ad hoc questionnaire sent to collect data about individual falls. 
Qualitative interviews with: 
Intervention participants (n=15-20) 
Firefighters, day duty safety advocates and home safety Safe and Well Officers 
delivering the intervention (n=15-20)  
Service leads (n=5) to understand the acceptability of the intervention. 
Monthly falls calendar sent to YTU 
Monthly falls calendar sent to YTU 
Participants sent a summary of the results once available. 

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3.3 
Participant assessment schedule  
 
 
Screening 
form 
Baseline 
Monthly data 
collection 
 
Randomisation 
(Eligible patients + 
BLQ + 1FC*) 
Approximately  
2-4 weeks post-
randomisation  
Post-
randomisation 
3/7/11.5 months 
post-randomisation 
4/8/12 months post-
randomisation 
Eligibility screening by 
researchers at YTU 
√ 
 
 
 
 
 
 
 
Postal informed consent  
√ 
 
 
 
 
 
 
 
Demographic data: DOB, 
gender 
√ 
 
 
 
 
 
 
 
Personal details: name, 
address, telephone number 
√ 
 
 
 
 
 
 
 
Contact details, GP details 
√ 
 
 
 
 
 
 
 
EQ-5D-5L 
 
√ 
 
 
 
 
 
√ 
Falls data 
 
√ 
√ 
 
 
 
 
 
Economic evaluation data 
 
√ 
 
 
 
 
 
√ 
Demographic questions: 
ethnic group, living 
arrangements 
 
√ 
 
 
 
 
 
 
Randomisation 
 
 
 
√ 
 
 
 
 
SWV **; intervention 
delivery checklist completed  
 
 
 
 
√ 
 
 
 
Observation of SWV  
 
 
 
 
√ 
 
 
 
Newsletter update 
 
 
 
 
 
 
√ 
 
Outcome data  
 
 
 
 
 
 
 
√ 
Adverse events 
 
 
√ 
√ 
√ 
 
√ 
√ 
Participant qualitative 
interviews  
 
 
 
 
 
√ 
 
 
Qualitative interviews with 
members of the FRS  
 
 
 
 
 
√ 
 
 
Qualitative interviews with 
service leads  
 
 
 
 
 
√ 
 
 
*BLQ – baseline questionnaire, FC – falls calendar;  ** SWV - Intervention participants only, control group receive after trial completion   

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3.4  
Plain English summary  
The Fire and Rescue Services routinely carry out around 670,000 fire safety visits each year 
in people’s homes.  The aim of these ‘Safe and Well Visits’ is to reduce fire risks, support 
independent living, improve quality of life, and help prevent avoidable hospital admissions 
and excess winter deaths.    
 
One part of the Safe and Well Visit (SWV) is looking at ways to prevent falls.  The FRS will 
work with people to help  them reduce their risk of falling.  This may be helping people to  
identify trip and fall hazards within their home, or suggesting they attend a falls prevention 
clinic.  For some people, falling can cause serious health issues and in some cases may be 
fatal.  About a third of people over the age of 65, and half of those over 80, will fall each 
year.  Most of these falls happen at home.  Falling may cause people to lose confidence, feel 
as if they have lost their independence and become withdrawn.  About a fifth of all of the 
falls people have need medical attention.  There were around 210,000 people admitted to 
hospital, as an emergency, in England in 2016 due to having had a fall.  It costs the NHS 
about £2.3 billion a year to treat patients who fall.  The problem is likely to get worse as 
people are living longer.  What we don’t know is whether Safe and Well Visits undertaken by 
members of the Fire and Rescue Service reduce falls and if they are good value for money.  
 
To find out if Safe and Well Visits reduce the number of falls people have, and improve their 
quality of life, we will conduct a trial.  We will recruit 1156 people aged 65 years and over 
from lists of people held on Fire and Rescue Service databases.  We will allocate half of the 
people to receive a Safe and Well Visit at the start of the study.  The visit will last about an 
hour and will be tailored to the risks of the people living in the household.  The other half of 
the people will receive the Safe and Well Visit after 12 months (when they have finished the 
study).  Everyone will receive a falls prevention leaflet from Age UK and their usual care 
from their GP and other health care professionals.  Participants will be asked to fill in 
monthly falls calendars and four questionnaires over 12 months to collect information about 
falls, their quality of life, how often they have used NHS services, and whether they are 
doing any activities that make them more likely to have a fire in their home.  This 
information may be collected over the phone or we may send questionnaires in the post.  
Researchers will analyse the data to find out if the Safe and Well Visits reduce falls and if 

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they are good value for money.  We also want to find out if the Safe and Well Visit is 
acceptable to and valued by older people and to the Fire and Rescue Service.  We will 
explore this through a series of in-depth interviews. 
 
Once we have completed the trial, we will make sure our results can be used by as many 
people as possible.  We will send the people who took part in the study a summary of our 
findings, and the results will be presented at relevant conferences and published in scientific 
journals.  We will share these findings with other Fire and Rescue Services. 
 
4. 
Background 
4.1 
Safe and Well Visits 
Fire and Rescue Services (FRSs) have traditionally delivered Home Safety Checks (HSC) in 
people’s homes to reduce their risk of fire and advise what actions should be taken in the 
event of a fire.  Many FRSs have expanded these HSCs to include health related themes.  
These include falls prevention; smoking cessation; social isolation; and winter warmth.  
Visits that include these health elements are usually known as Safe and Well Visits (SWV).  
The SWV target households known to have a higher risk of fire (likelihood and/or 
consequences) such as occupants aged 65 years  and over, people with poor mobility, and 
people who have a history of alcohol or tobacco dependency.     
 
The aim of the SWV is not only to reduce fire risk, but to support independent living, help 
prevent avoidable hospital admissions and excess winter deaths, and to contribute to 
improving quality of life particularly for people aged over 65.  The FRS carry out 
approximately 670,000 Fire Safety Visits in people’s homes each year in England (1).  There 
is some evidence to indicate that these visits are effective.  The Winter Pressures Pilot 
service evaluation, commissioned by Public Health England (PHE) and the Chief Fire Officers’ 
Association (CFOA), was conducted between October 2015 and March 2016.  It aimed to 
reduce the risk of winter-related ill health in vulnerable groups of people (2).  The 
evaluation found that the home visits were more effective in addressing falls, cold homes 
and social isolation, but less effective at influencing the uptake of flu vaccinations.  
However, this was not a randomised controlled trial (RCT) and potential improvements to 

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quality of life were not considered, nor was a full economic evaluation undertaken [insert 
ref] .    
 
4.2   
Fire and falls 
There are common risk factors for fire and falls.  For example, older people and those with 
mobility problems are at increased risk of falling and at increased risk of injurious fires (3) as 
they may have difficulties getting out of their home, especially if they have fallen and cannot 
get up.  There may also be common, modifiable risk factors for both fires and falls such as 
unsafe items in entrances/exits or hoarding.   
 
Falls in older people are highly prevalent and can have serious consequences.  Approximately 
a third of people over the age of 65 years, and half of those over 80, will fall each year (3-5). 
Fall related fractures are a serious cause of morbidity and cost to society (6).  A fifth of all falls 
are serious and require medical attention with 5% of falls leading to a fracture.  This has a 
major impact on health care resource use, primarily due to fractures.  Falling can cause people 
to lose confidence and independence, and become withdrawn.  Repeated falls commonly 
precipitate admission to institutional care.  They tend to be experienced by those over the age 
of 75 years, who are more frail and are more likely to sustain hip fractures due to slowed 
protective reflexes or have underlying medical conditions such as osteoporosis (3, 7).  There 
were around 210,000 falls-related emergency hospital admissions in England in 2016/2017 (8) 
costing the NHS more than £2.3 billion per year to treat (5).  If we can reduce the proportion 
of people who fall and the number of falls people have, there could be a large impact on 
admissions to hospital due to fall related injuries and consequent savings in primary and 
secondary care costs. 
 
Approximately 85% of falls occur in the home.  Environmental hazards are implicated as a 
major contributor to falls among older people and are frequently cited as causes of falls in the 
literature.  One review described ‘accident/environment related’ factors as responsible for a 
mean of 31% (range 1-53%) of all falls (n=3,628) across 12 studies (7). The latest Cochrane 
review of interventions for preventing falls in older people living in the community (9) 
identified six trials, involving 4,208 participants, evaluating a home safety assessment and 

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modification.  They concluded that home safety assessment and modification interventions 
were effective at reducing both the rate of falls (relative risk of rate of falling 0.81, 95% CI 0.68 
to 0.97) and risk of falling (relative risk of falling 0.88, 95% CI 0.80 to 0.96).  They also 
concluded that these interventions were more effective in people at higher risk of falling, and 
when delivered by an occupational therapist (OT).  However, the conclusions of this review 
are not supported by the recent findings of the National Institute for Health Research – Health 
Technology Assessment funded OTIS trial [in press]. This trial found home hazard assessment 
and modification delivered by an OT did not reduce falls in community-dwelling older people 
deemed at higher risk of falling recruited to this trial.  Whilst four of the trials included in the 
Cochrane review involved non-occupational therapists, none involved members of the FRS 
delivering a home assessment or modifications. Members of the FRS are not only concerned 
with the health consequences of falling, but also the need to get out of a property in the event 
of a fire.  Whether this will motivate people to undertake the changes required to reduce risk 
of falls is unknown.  In addition, the FRS are unlikely to change their practice around falls 
prevention based on the OTIS results, as this evaluated an OT falls prevention intervention 
and not one delivered by members of the FRS.  Another Cochrane review (10) concluded that 
multifactorial interventions may reduce the rate of falls compared with usual care, although 
the quality of the evidence was rated as low.  There is growing evidence to suggest that early 
identification, multifactorial assessment and early intervention can make a significant impact 
on an individual’s risk of falls.  As many falls are caused by simple hazards (7) such as trip 
hazards, it could be that if the FRS were able to identify and remove trip hazards or 
recommend relatively simple home modifications, coupled with onward referral to other 
services, then this could lead to a reduction in falls.   
 
4.3  
Smoking and risk of fire  
In 2019, the proportion of current adult smokers in England was estimated at 14.1%.  Men 
are more likely to smoke than women (15.9% compared to 12.5%) whilst those aged 65 
years and above were less likely to smoke (7.8% compared to 13.9% in those aged 55 to 64, 
15.9% in those aged 45 to 54, 15.5% in those aged 35 to 44, 19.0% in those aged 25 to 34, 
and 16.0% in those aged 18 to 24) (11).  However, since 2012, the city of Kingston Upon Hull 

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has been in the ten local authorities with the highest proportion of current smokers at least 
seven times, with 22.2% of the population reporting they smoke (11).  
 
Smoking within the home increases the fire risk within the home.  In 2018/19 smokers’ 
materials were reported as the source of ignition in 10% of accidental dwelling fire non-fatal 
casualties and 34% of fire-related fatalities.  Fires caused by smoking materials result in 
more deaths than any other type of fire (12). Within the population as a whole, men were 
found to have a greater likelihood of dying in a fire than women.  For men aged 65 to 79 the 
fatality rate was 9.6 per million compared to 6.2 per million for women.  This increased to 
20.6 and 14.5 per million respectively for those aged 80 years and over (13).   
 
Over the last decade, there has been an increase in the number of people vaping and using 
personal vaporisers.  There are an estimated three million adult vapers in Britain, almost all 
of whom are smokers and ex-smokers (11).  Use of such devices is not risk free. There is 
both risk of fire and a risk of poisoning from ingestion of e-liquids.  In March 2016, it was 
reported that there were 113 fires caused by e-cigarettes in three years, whilst Incident 
Recording System data from the FRS showed there were over 16,000 smoking related fires 
in the same period (12).     
 
Smoking also has a well documented detrimental impact on the health of both the smoker 
and those exposed to second and third-hand smoke.  Tobacco (both active smoking and 
environmental tobacco smoke) causes almost a fifth of all cancer cases in the UK (14).  
Regular exposure to second-hand smoke can cause non-smokers to develop the same range 
of diseases as smokers, including lung cancer and heart disease.  Children are especially 
vulnerable to the effects of second and third-hand smoke (11).  
 
Smoking is the leading cause of preventable deaths in the UK.  In 2016 there was an 
estimated 77,900 deaths attributable to smoking, representing 16% of all deaths across the 
UK (11).  It accounted for around 474,300 NHS hospital admissions in 2015 to 2016.  It is one 
of the leading cause of socioeconomic inequalities in health in the UK.  The difference in life 
expectancy between the poorest and richest can be as much as nine years (11), of which 

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approximately half can be attributed to smoking.  According to the Government’s Tobacco 
Control Plan for England, smoking costs the NHS £2.5 billion per year (15).   
 
In addition to the reduced fire risk within the home and financial benefit to the individual, 
there are both immediate and long-term health benefits of smoking cessation.  After three 
to nine months, lung function improves by 10%.  After five years the risk of having a heart 
attack falls to about half that of a smoker.  Stopping smoking also decreases the risk of many 
diseases related to second-hand smoke in children, such as asthma (16).   
 
As part of the SWV, the FRS will use the Making Every Contact Count approach using the 
opportunities that arise during the SWV to help people make positive changes to 
their health.  People will be given advice about smoking cessation, safer smoking practices, 
and signposted to stop smoking services.  Whilst it is recognised that it is difficult to 
change smoking behaviour in one visit, SWVs can ensure people who continue to  smoke 
do so in the safest way such as not smoking in bed, smoking outside and use of proper 
ashtrays.   
 
4.4 
Social isolation and loneliness  
The term ‘social isolation’ refers to a lack of regular contact with family and friends or lack of 
involvement in social organisations.  Whilst loneliness is a subjective state based on a person’s 
emotional perception and it describes the sense of being alone or lacking affection or 
closeness with others.  It is possible for someone to feel lonely but not be socially isolated.  
However, social isolation and loneliness are often weakly correlated (17, 18) .   
Loneliness and social isolation are risk factors for all cause morbidity and mortality with, risks 
comparable to those such as smoking, lack of exercise, obesity and high blood pressure (19-
21).  They also impact on use of public services with socially isolated and lonely individuals 
more likely to visit a GP, visit A&E or go into residential care.  Socially isolated individuals are 
also more likely to suffer from depression, and have an increased risk of developing diabetes 
or suffering a stroke or developing coronary heart disease (22).  It has been suggested that 
tackling loneliness among older people may be a way of enhancing wellbeing and delaying or 
reducing demand for institutional care (23).  Addressing social isolation and loneliness is 

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challenging.  If the FRS identify this as an issue, they will signpost to other available services, 
such as befriending services.   
 
4.5 Cold homes and winter warmth  
Older people are particularly vulnerable during cold periods.  There is some evidence to suggest 
that cold temperatures can cause increased blood pressure, which may lead to an increased risk of 
stroke (24) and can trigger respiratory conditions such as asthma and chronic obstructive 
pulmonary disease (25).  These poor health outcomes contribute to inequalities in health.  There is 
also evidence linking home temperatures and mental  health, with increases in room temperature 
associated with reduced likelihood of experiencing anxiety and depression (26). In addition, cold 
temperatures can exacerbate existing medical conditions such as diabetes, ulcers and 
musculoskeletal pains and exacerbate symptoms of arthritis (27). Moreover, winter mortality 
rates in those aged 75 years and over increases by about 30% during winter and cold homes and 
influenza are likely to contribute to this figure (28, 29).  Since it has been estimated that 21.5% of 
excess winter are attributable to the coldest 25% of homes (30) tackling cold homes may 
therefore be one way to improve health outcomes and reduce inequalities in health in England.  
As part of the SWV, depending on the time of year, advice about how to safely keep the home 
warm, and financial schemes to enable this will be discussed.   
4.6  
Aim of the research  
This protocol has been designed in response to a commissioned call from the National 
Institute for Health Research (NIHR) Public Health Research (PHR) Programme, which asked 
the question “which fire and rescue safety and health-related interventions are effective at 
improving health outcomes and reducing health inequalities?”.  As the SWV cover a broad 
range of interventions, evaluating the SWV in its entirety would be challenging.  With the 
agreement of the funder, we have specified that the main focus of this evaluation will be on: 
i) the falls prevention aspect of the visit, and ii) improving health-related quality of life.  We 
recognise the importance of the other areas covered by the SWV and so we have also 
included a number of important secondary outcomes. 
  

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4.6.1 Primary aim  
The primary aim of this study is to establish whether SWVs delivered by the FRS will lead to 
a reduction in the number of falls and an improvement in health-related quality of life 
among older people living in the community.   
 
4.6.2 Secondary aims 
Secondary aims include: 
 To establish the cost-effectiveness of the SWV delivered by the FRS at reducing falls 
and improving health-related quality of life for older people living in their own 
homes. 
 To investigate adherence to recommendations made during the SWV and to explore 
the acceptability of SWV to older people and the FRS. 
    
5 
 Study design  
   
5.1 
Study design  
FIREFLI is a pragmatic, two arm, randomised controlled trial, with embedded qualitative and 
economic evaluations. 
 
5.2 
Identification of sites  
The trial will be undertaken in the geographical locations covered by Humberside and Kent 
FRSs.  If additional sites are required, then members of the study team based in the FRS will 
identify and invite other potential FRSs to take part in the study.   
 
5.3  
Identification of participants to receive an invitation mail out  
We will recruit 1156 men and women, aged 65 years and over, to the trial.  Potential 
participants for the invitation mail out will be identified by searching databases held by the 
participating FRS. The Fire and Rescue Serivce routinely receive data from Experian on which 
they carry out risk profiling in order to identify households to offer a SWV that are most at 
risk from fire fatality . This is combined with Exeter data from the NHS to refine the age 
group to those 65 years at Humberside Fire and Rescue Service and to those 70 or over at 

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Kent Fire and Rescue Service  - the priority group for SWVs. The search will identify 
households  with a high probability of to having an occupant aged  65 years and over within 
the Humberside area or aged 70 or over in the  and Kent and Medway area. (The age criteria 
for inclusion in our study have been updated in response to the lower than anticipated 
recruitment rate and to better reflect the usual practice of the participating Fire and Rescue 
Services, with Humberside Fire and Rescue Service including those 65 years and older in 
their priority group for a Safe and Well Visit and Kent Fire and Rescue Service focussing on 
those aged 70 and over).   Nursing and residential homes identified during the search (for 
example, the address includes the words nursing or residential home) will be excluded from 
the mail out.  An additional risk profile may be undertaken in order to prioritise those most 
at risk.  For example, in Humberside, the risk profile is based on whether the householder 
lives alone, smokes, has mobility problems, or has impairment by alcohol or substances.  
Households that are deemed very high risk of fire, will be excluded from the mailout since 
they will require a SWV as soon as possible, and it would be unethical to ask those allocated 
to the control group to wait 12 months for their visit.  Equally, those deemed at very low risk 
will not be prioritised, as they would not normally be seen by the FRS.  If there are more 
households on the list to mail out to than needed, a random sample will be selected.  
 
In order to undertake this database search, we will: 
i) 
Apply for Health Research Authority (HRA) and Confidentiality Advisory Group 
(CAG) approval. 
ii) 
Put data sharing agreements in place between the University of York and Kent 
FRS and Humberside FRS.   
iii) 
Seek and follow the advice from NHS England and NHS Improvement about the 
use of Exeter data (patient data held on the National Health Application and 
Infrastructure Services system which the FRS routinely have access to for 
research purposes).   
  
Following review by CAG, the committee has suggested an alternative data flow to the one 
outlined in the application.  In their suggested method, the FRS will (1) search the routine 
data they hold, for households with anyone over the age of 70 years, (2) they will then 
remove any household which has had a SWV in the past 3 years or due a visit within the 

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next 12 months (3) they will also remove any property with a nursing or residential home 
address.  (4) The FRS will then send NHS England and NHS Improvement a list of Unique 
Property Reference Numbers (UPRNs) corresponding to these households.  (5) NHS England 
and NHS Improvement will search this list and will remove any household which has opted 
out of being contacted about research (via the National Data Opt-out).  They will then send 
the FRS the list of addresses on this list.  This list will be used by the FRS to undertake the 
mail out.   The advantage of following this data flow is that it minimises the transfer of 
identifiable data, as UPRN is open data.   
 
Due to the considerable delays and challenges of using the Exeter data to produce a list of 
households to mail out to, we would like to implement an alternative/ additional strategy to 
approach potential participants. As an alternative to using the Exeter data to produce a list 
for the recruitment mail out, as described above,  the FRS will also use their Experian Mosaic 
data on its own to identify households for the invitation mailout. This process will be as 
follows, and similar to the process using the Exeter data: 
i. 
The FRS will identify the Experian Mosaic groups to target, which will focus on older 
people. Mosaic data classifies people into socio demographic groups which can be 
used to identify people that are more likely to fall into the target group for this trial. 
For example, Group N known as ‘Vintage Value’ is described as “elderly people who 
mostly live alone, either in social or private housing, often built with the elderly in 
mind”. Levels of independence vary, but with health needs growing and incomes 
declining, many require an increasing amount of support”. Experian use data to 
identify the likelihood of someone falling into each group. If no data is available for 
an individual address then data for neighbouring addresses is used. Therefore 
although the model is very good at predicting the socio demographic group for an 
address it is on a probability basis. No personal data is included within the dataset. 
ii. 
The FRS will produce a list of households that fall into that target group 
iii. 
The FRS will then exclude households that have received a SWV in the last three 
years, or have one booked, and where possible, where other identifies these risks, 
the other groups outlined above who would not be eligble for the study (those 
households at very high risk of death due to fire, those at lowest risk, and those 
households that are nursing/ residential homes.  

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iv. 
The list thus produced will be used to post out a recruitment pack to those 
households in the list.  
 
Due to the nature of  the Experian Mosaic data, the list of households produced may also 
include residents under the age of eligibility for the trial (65 years or older at Humberside or 
70 years or older at Kent).  Therefore the study documentation for this mail out will be 
amended to clarify the eligibility criteria for the trial.  In addition, information about how 
ineligible people can access a SWV outside of the trial will also be included.  The Experian 
Mosaic data may result in a less targeted mailout in terms of age, an issue which has been 
discussed with the study's Trial Steering Committee. However, the FRS use Experian data to 
risk profile the population to prioritise the SWV delivery in usual practice so the group 
defined by the mailout for the study will be similar to that approached for a SWV in routine 
service delivery.  (All trial particpants have to fulfil eligibility screening before they enter the 
trial so the resultant trial population will only include those who do meet the relevant age 
criteria at each site (aged 65 or over for Humberside and  aged 70 or over for Kent).  Given 
the prolonged issues the trial has had with using the Exeter data to undertake the mail out 
and the need to be able to move the trial forward and start recruitment, the Trial Steering 
Commitee were supportive of this strategy.   
 
Households identified as eligible for a mail out will be posted an invitation pack.  The pack 
will contain an invitation letter, addressed to the occupier, as opposed to a named person in 
the household, from the FRS asking if a member of the household, aged 65 (Humberside)/70 
(Kent) years and over, would like to participate in the study.  It will also include a participant 
information sheet, consent form, screening questionnaire and two pre-paid envelopes.  The 
letter will explain that only one participant per household will be permitted to take part in 
terms of completing data collection (though all household members may benefit from the 
SWV).  If more than two people in the household over the age of 65 (Humberside) /70 (Kent)  
express an interest in taking part, then we will include the oldest person, as they are likely 
to have the greater risk of falling.  Participants who are unable to speak or read English will 
be able to participate in the study, if they have a family member or friend who is willing to 
translate/interpret for them. 
 

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Changes to the mailout in respone to low recruitment. 
Due to a lower than predicted response to the postal invitations, at a rate of around 3%  
rather than the anticipated 6%, modification is  is being made to the study materials initially   
sent out to the participant. The low response rate was discussed at our Trial Management 
Group meetings and with our Trial Steering Committee and various changes were proposed 
to try and increase uptake.   
One such change was to modify the materials sent out to potential participants with the 
initial mailout. It was felt that perhaps the volume of trial documents sent to particpants 
may discourage people to take part. Therefore, instead of households identified from the 
FRS database searches being sent the full recruitment pack, as described above, which 
contains an invitation letter, a lengthy trial Participant Information Sheet, a Screening 
Questionnaire Consent form and Contact Sheet to complete, we will send these residents a 
brief ‘Expression of Interest’ letter. This letter will include a short explanation of the study 
and  give details of how to find out more about the study. The shorter ‘Expression of 
Interest’ letter will also contain information on how to receive a Safe and Well Visit from the 
Fire and Rescue Service if they do not want to participate in the trial. The initial mailout will 
also contain a contact details form that people can complete and return to York Trials Unit , 
in the Freepost envelope provided, if they are interested in taking part in the study and 
would like more information. Alternatively, they can telephone the research team at the 
YTU. Those who do express an interest in the study in response to this mailout will then be 
sent the full recruitment pack.   Sending the full recruitment pack to only those who are 
interested will cut down on printing costs and paper wastage. 
 
5.3.1  Opting out of the  mail out  
 
We are aware that we will be approaching households via a mail out without their consent 
at this first phase of the study. We want to enable people to opt out of receiving an 
invitation recruitment pack if they do not wish to be included. This will require a period of 
pre-notification where we will provide information in advance, that the mail out will be 

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occurring.  Information about how to contact the FRS to express their dissent at receiving a 
pack will be included.   
 
We will notify members of the public about the mail out of recruitment packs in a variety of 
locations- using the same platforms we propose for advertsing for participants ( as detailed 
in section 5.3.2). At the request of CAG, we will also explain that the FRS already receive 
data from the NHS in order to offer Safe and Well visits, in case people wonder how the FRS 
access their data.   
 
5.3.2 Advertising for participants  
 
We may also advertise for participants to take part in the trial.  This may include: radio, 
newspaper, on websites e.g. the recruiting FRS and University of York, ‘My Community Alert 
e.g. https://www.mycommunityalert.co.uk/’,  ‘ next door’ 
https://go.nextdoor.com/ukpublicservices, social media platforms such as Instagram, 
Facebook, Twitter, television and other media advertisements; flyers or posters within the 
recruiting area e.g. libraries; Primary Care Centres, GP practices or through organisations 
such as the University of the Third Age, Age UK, Women’s Institute, Townswomen’s Guilds, 
the Rotary Club, Over Sixties clubs, faith organisations, Parish councils, ward newsletters, 
Police and Crime commissioners engagement network, Fire Authority passing information 
on to their constituents, and Neighbourhood networks.  Opportunistic screening of family 
members or friends of people who receive a study information pack may also be 
undertaken.  
 
 
5.4  
Declining participation in the study 
Participation in the FIREFLI study is voluntary.  People who do not wish to take part in the 
study will not have to return any forms to the YTU.  They will not have to give a reason why 
they do not wish to take part but if a reason is provided it will be recorded.  People who do 
not respond to the invitation mail out will not receive any further correspondence from the 
YTU about the study.   

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5.5  
People who wish to take part in the study 
People wishing to take part in the study will be asked to return their completed consent 
form with a contact form to the YTU and their screening questionnaire, separately by post 
to the YTU.   
 
5.5.1 
Assessment of eligibility  
 
Researchers at the YTU will assess the returned screening form for participant eligibility 
according to the criteria in section 6.  If a person is found to be ineligible for the study, for 
example if they have had a SWV within the past three years, they will be informed in 
writing.  No further correspondence will be sent from the YTU. 
For those who have responded to advertisements about the study, or contacted the 
research team directly as they have heard about the study other than through the mailout, 
an additional step of eligibility checking will be required to see if that person is eligible for a 
Safe and Well visit by the FRS. (This extra check of eligibility for a Safe and Well Visit with 
the FRS is not required for the mailout method of recruitment as invitations are only mailed 
out by the FRS to priority groups who are eligible for a Safe and Well Visit). 
 
For this alternative recruitment via advertising, outside of the mailout, researchers at the 
YTU will first determine if the person is eligible for the study by asking the potential 
participant the eligibility criteria questions on the screening form over the telephone.  If 
eligible at this point, these potential particpants will be sent a recruitment pack including a 
specific Participant Information Sheet. This information sheet includes details about the 
study and includes that we will need to confirm with the FRS if they are eligible for a Safe 
and Well visit. In order to confirm this YTU will need to share the potential participant’s 
address with the FRS. The recruitment pack will also contain a specific consent form, which 
includes a point to confirm that they agree to share this data. The potential participants will 
be asked to return the study documentation to YTU  in order to confirm if they are eligible 
to take part in the study.   
 

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Once the participant has returned the completed screening questionnaire to YTU, 
researchers will check the participant is eligible for the study by assessing the returned 
screening form, and if the participant is deemed eligible and has agreed to their address  
being shared with the FRS as indiciated on their consent form, a further check will be 
undertaken with the FRS to see if that person is eligible for a Safe and Well Visit. If they are 
eligible for a SWV by the FRS, then the participant will be enrolled in the study and sent a 
baseline questionnaire and pack of falls calendars.  Any who are assessed as ineligible, will 
be notified by letter and given information about how  they may be able to have a SWV 
outside of the study.   
  
5.5.2 
Informed consent and completion of the consent form  
  
If respondents require any further information about the study prior to giving their consent 
to take part they will be able to contact members of the research team based at the YTU, 
who will have undertaken Good Clinical Practice (GCP) Training.  If the respondent prefers, a 
family member, friend, carer or other nominated person may contact the YTU on their 
behalf.  Respondents will have at least 24 hours to consider participation in the study.  
People who wish to take part in the study will be asked to write their name on, sign and 
date the consent form.  They will also initial each of the consent statements to indicate they 
agree with them.  If, however, a participant places a tick or a cross against the consent 
statements rather than their initials, these shall be taken as an indication of consent.  
Nevertheless, all due care will be taken to ensure that the participant has provided consent 
to take part in the study. There will be a specific consent form for use with direct 
recruitment in response to advertisement, as opposed to the mailout route, as there is an 
additional data sharing step associated with the direct recruitment method. This has been 
added to a statement on this specific consent form for direct recruitment to seek 
participant’s agreement.  As the consenting process is postal, we have to work on good faith 
that the person signing the consent form is who they say they are.  If we have a completed 
screening form and valid consent form, we will make the assumption that the person has 
capacity and that the screening form has been completed by the person signing the consent 
form.  If the study team at the YTU has any doubts about whether a person wishes to take 
part in the study they will telephone them to confirm.  Patients may nominate a family 

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member or friend to talk to the trial team on their behalf.  This will be documented on the 
consent form.    
 
 
Throughout the course of the study, we will assume continuing capacity unless we have 
proof otherwise or at the start of the study consultee approval was required.  During the 
study, we will have contact with participants and consultees when we telephone to collect 
data for example about falls, or review responses from follow-up questionnaires and falls 
calendars.   If a concern about mental capacity is raised during the course of a conversation 
with a participant (or family member/friend/carer if they have consented to this in the main 
trial consent form), or from something written on a questionnaire or falls calendar received 
by the research team, the researcher will telephone the participant (or family 
member/friend/carer if indicated on the consent form) to further reassess the mental 
capacity of the individual.   
  
 
5.5.3 
Informed consent and completion of the consent form in participants lacking 
capacity  
 
In line with the first principle of the Mental Capacity Act 2005 (MCA), our starting point will 
be that a person has capacity to make a decision (in this case, wishing to take part in the 
FIREFLI trial) unless proved otherwise.  Therefore, any potential participant who returns a 
completed consent form and screening questionnaire will be deemed to have capacity.   
However, given the age of the population it is expected that some potential participants will 
have cognitive problems such as dementia, which may affect their ability to process 
information, make informed decisions about their involvement in the trial and provide 
outcome data.  This population are, however, at a higher risk of falling due to problems with 
balance and mobility, medication side effects and depression (31).  In addition, the FRS 
would routinely undertake SWV in homes where an occupant has cognitive problems.  We 
therefore consider that those with impaired capacity have as much to gain from inclusion in 
the study as those with full capacity.  They will be included in the study if they live with 

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someone who agrees to act as their personal consultee and provide outcome data where 
needed.   
 
Participants who lack capacity will be identified in one of the following ways: 
 
(i) 
The screening questionnaire will include the following question. “Do you have a 
condition or impairment that affects your memory, thinking or ability to make 
decisions?”  Those who respond ‘Yes’ to this question will be asked to read a 
further statement, which informs them of the need for the study team to talk to 
a family member or friend.  If the potential participant is happy for the study 
team to do this, the participant will be instructed to ask their family member to 
read the information sheet they were sent and then write their name and 
contact details at the end of the contact sheet.  The research team will then 
contact the potential consultee by phone.  
(ii) 
The main participant information sheet includes information about being a 
consultee and who to contact for further information and discuss trial 
participation.   
 
The process of seeking consent to be in the study for participants lacking capacity will be 
approved by the Research Ethics Committee and in accordance with the MCA 2005 .  The 
MCA establishes a framework for the protection of the rights of people who lack the 
capacity to make a decision themselves. It is designed to ensure that the interests and rights 
of people who lack capacity are protected and that their current and previously expressed 
wishes are respected.  
 
A personal consultee will be someone who knows the person lacking capacity and is able to 
advise about the person’s wishes and feelings in relation to the study.  Due to the 
requirement to report falls outcome data, the consultee will have to be a person living in 
the same household, but should not be someone who is acting in a professional or paid 
capacity.  
 

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The consultee will initially be informed about the trial by reading the information provided 
in the invitation pack.  Once identified, the research team at the YTU will send a consultee 
Information Leaflet which includes information about the role of the consultee.   They will 
be asked to advise on what the participant’s wishes and feelings would be about taking part 
and whether they would be agreeable to taking part in such research or if they would have 
objections.   A member of the research team from the YTU (who was formerly a General 
Practitioner or a nurse, who has received training and is experienced in assessing patient’s 
capacity) will contact the consultee by telephone or using an on-line platform such as Zoom 
or Skype according to the consultee’s preference, to discuss the study, answer any 
questions the consultee has and if necessary, undertake a capacity assessment.  Should a 
suggested consultee feel unable to take on this role, then the potential participant will be 
deemed ineligible for the study and the consultee and potential participant will be thanked 
for their time.   
 
The capacity assessment will be based on the HRA e-learning module on research involving 
participants lacking mental capacity and the BMA Mental Capacity Act Toolkit.  As far as 
practically possible, we will include both the participant and the consultee in the discussion 
about taking part in the study.  During the discussion, the following will be discussed in 
order to make an assessment of the mental capacity of the individual: 
 Consideration of the participant’s medical history to determine if there is a cause for 
impairment of brain or mind. If no, the participant will be able to give informed 
consent and will be asked to complete the participant consent form and study 
documentation; if yes, we will consider if this impairment affects the person’s ability 
to make a decision. 
 Determine if they are able to understand information about the study.  
 Determine if the participant can retain the information for long enough to make the 
decision, weigh up the information to make the decision about taking part and let us 
know about their decision.  
 We will ask the consultee to help and support the process but will take into account 
the person’s views, wishes and beliefs and make an objective assessment of whether 
taking part in the research is in their best interest.   

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During the discussion, we will be careful to make sure we use appropriate language and not 
use technical wording. We will avoid questions which would be answered with ‘yes’ or ‘no’ 
replies.  
 
We will keep a record of the process of assessing mental capacity; for those that do not 
agree to take part in the study, we will confidentially destroy this information after the 
letter of ineligibility has been sent.   
 
If the personal consultee decides that the patient would have no objection to participating 
in the research then a Personal Consultee Declaration Form will be completed. 
 
Copies of the consent forms and Consultee Declaration Forms will be stored at the YTU in a 
locked cabinet in a locked room and in accordance with the YTU Standard Operating 
Procedures (SOPs).  Identifiable data will be stored separately to pseudononymised data 
(i.e. where a unique trial identification number is used to identify the participant).  A copy of 
the completed consent form/consultee declaration will be sent back to the 
participant/consultee.   
 
5.5.4 Completion of the baseline questionnaire  
 
All eligible, consenting participants will be sent a baseline questionnaire and a batch of 
monthly falls calendars by post.  Participants who return a valid baseline questionnaire and 
at least one falls calendar within the three months prior to the point of randomisation will 
be randomised into the trial.   
 
Our preference would be for participants to complete study documentation via the post;  
however, in order to mitigate the potential impact COVID-19 may have on the running of 
the study, data may be collected over the phone instead.   
 
6. 
Eligibility criteria for the FIREFLI trial  
 

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6.1  
Assessment of eligibility  
 
6.1.1 
Inclusion criteria 
 
Potential participants will be eligible for the trial if they fulfil the following criteria: 
 Men and women aged 70 years and over, if they live in the area covered by Kent Fire 
and Rescue Service, or aged 65 years and over if they live in the area covered by 
Humberside Fire and Rescue Service  
 
 Live in the community within geographical areas covered by the participating FRS 
 
6.1.2 
Exclusion criteria  
Potential participants will be excluded if they fulfil any of the following criteria: 
 
Live in residential or nursing home 
 
Unable to give informed consent and live alone  
 
Are bed bound 
 
Have had an occupational therapist visit within the past 12 months  
 
Have had a SWV within the past three years 
 
Have been referred to the FRS or have already requested a SWV within 12 months   
 
Are unable to read or speak English and have no friend or relative who is willing 
and able to translate/interpret for them 
For those participants who have been sent a recruitment pack directly from YTU in 
response to advertising or hearing about the study, as opposed to receiving an invitation 
and recruitment pack via the mailout from the FRS, a further eligibility check is required 
to see if the participant is eligible for a Safe and Well Visit by the FRS and therefore, in 
these circumstances, there is another exclusion criterion: 
 Not eligible for a Safe and Well Visit with the FRS 
 
N.B. People who suffer from dementia, or who have other cognitive impairments may be 
included in the trial if they live with someone who agrees to act as their consultee and 
provide outcome data on their behalf where needed.    

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6.2 
 Primary outcome 
There are two primary outcomes: 
i) 
The number of self-reported falls per participant over the 12 months from 
randomisation (a fall is defined as an ‘unexpected event in which the participant 
comes to a rest on the ground, floor or lower level’ (32) 
ii) 
Health-related quality of life as measured by the 5-level version of the EuroQoL 5 
Dimensions (EQ-5D-5L) over the 12 months from randomisation.   
 
6.3 
Data collection for the primary outcome for the trial 
6.3.1     Falls data  
Participants will be asked to record on monthly falls calendars if, in the past month, they 
had any falls including a slip or trip in which they lost their balance and landed on the floor, 
ground or lower level.  An explanation of what the researchers consider to be a fall will be 
included in the participant information sheet, on the falls calendars and in the newsletters.  
If a participant is uncertain as to whether an event is classified as a fall, then they will be 
encouraged to ring the research team at the YTU to discuss.  Data will be collected via 
participant self-reported monthly falls calendars in the 12 months following randomisation.  
Falls calendars will be sent to participants in the post along with their baseline 
questionnaire.  If they had a fall that month, participants will be asked to mark on the 
calendar the number of falls they had on each day and return their monthly falls calendar to 
the YTU via FREEPOST.  Participants who do not return their falls calendar within 10 days of 
the due date will either be telephoned, or sent a reminder letter in the post by the YTU, to 
collect this information.  We will also collect falls data at four, eight and 12 months after 
randomisation using a participant postal questionnaire.  The falls data from these 
questionnaires will be used for those participants who do not return their monthly falls 
calendar and cannot be contacted by phone.   
 
Participants will also be given the YTU free phone number to ring during office hours to 
report any fall they have as soon as it is safe and convenient for them to do so.   
 

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YTU personnel will follow up every reported fall to collect information on the cause/reason 
for fall, consequence of fall e.g., superficial wound (bruising, sprain, cut, abrasions), 
fractures (including type of fracture) and hospital admissions.  This information will be 
collected either by postal questionnaire or via a phone call to the participant.     
 
6.3.2   Health-related quality of life (EQ-5D-5L) data  
Health-related quality of life will be measured using the 5-level EuroQoL 5 Dimensions (EQ-
5D-5L)(33) over 12 months.  This generic, validated, patient-reported outcome measure 
(34)(www.euroqol.org) has five health domains (mobility; self-care; usual activities; 
pain/discomfort; and anxiety/depression) with five response options for each domain (no 
problems, slight problems, moderate problems, severe problems, and extreme problems). 
In addition, it has a health status visual analogue scale (VAS) that measures self-rated health 
anchored at 0 (‘the worst health you can imagine’) and 100 (‘the best health you can 
imagine’) .  The measure is easily completed.  The EQ-5D-5L will be collected at baseline, 
and at four, eight and 12 months post-randomisation by questionnaires sent in the post by 
the YTU. 
 
6.4 
Secondary outcomes and other important data 
 
Secondary outcomes in this study are:  
 
 
Fall related secondary outcomes: As recommended in the Cochrane review of 
interventions for preventing falls in older people living in the community (9), the 
following outcomes will be measured: time to first fall from date of randomisation 
and time between subsequent falls; proportion of participants reporting at least 
one fall in the 12 months from randomisation; and the proportion of participants 
reporting multiple (two or more) falls in the 12 months from randomisation. 
 
Fear of falling: Participants will be asked at baseline and at four, eight and 12 
months post-randomisation to score how often they have worried about having a 
fall in the past 4 weeks.  Six response categories will be used (all of the time, most 
of the time, a good bit of the time, some of the time, a little of the time, and none 

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of the time).  These will be scored from 1 to 6, with higher scores indicating less 
concern about falling. 
 
Fall related injuries and costs: See economic evaluation sections 6.3.2 and 8.8 for 
further details. 
 
Patient self-reported fractures. 
 
Loneliness: Participants will be asked at baseline and at four, eight, and 12 months 
post-randomisation to complete the UCLA 3-item loneliness scale that comprises of 
three questions that measure three dimensions of loneliness (35, 36). These are 
relational connectedness, social connectedness, and self-perceived isolation.  Each 
question is rated on a 3-point scale (hardly ever, some of the time, often) with 
higher scores indicating greater degrees of loneliness. 
 
Flu jab uptake: Participant self-reported uptake of a flu jab in the 12 months from 
randomisation.  
 
Smoking status: Participant self-reported smoking or vaping status of occupants 
within the household, smoking inside the property, smoking in bed, referral to NHS 
stop smoking services collected at baseline, four, eight and 12 months.   
 
Participant-reported fire within the property that the FRS attended and fire within 
the property that the FRS did not attend over 12 months.  
 
Fire risk taking behaviours: Participants will be asked at baseline, and at four, eight 
and 12 months post-randomisation, to indicate whether they undertake any of the 
following behaviours: use of candles, chip pans, and portable heaters,  use of  
paraffin based skin creams; cooking left unattended; history of cooking related fire; 
maintenance of electrical wiring as determined by the presence of scorch marks on 
plugs or electric sockets; testing smoke alarms; and smoking habits such as falling 
asleep whilst smoking; shutting internal doors at night; escape plan; ability to 
escape in event of a fire; fire safety knowledge.  A summary score of the number of 
behaviours identified will be calculated.   
 
Number and reason for attendances to participant’s homes by the FRS 12 months 
pre-randomisation and in the 12 months from randomisation. 
 

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6.5 
Data collection for secondary outcomes  
Secondary outcome data will be collected by monthly falls calendars and postal questionnaires 
sent at four, eight and 12 months post-randomisation.  The postal questionnaires will collect 
data on: fear of falling, fractures, health resource use data, uptake of flu jab within the past 12 
months, loneliness (UCLA 3-item), smoking status, smoking inside the property, smoking in bed, 
and referral to stop smoking services, EuroQoL 5 Dimensions (5L) utility score (EQ-5D-5L) and 
fire risk taking behaviours.    
  
The following data will be collected from the FRS: date the SWV(s) was/were conducted; 
referrals made (for example, to falls clinics, occupational therapists, etc); advice given; cost 
of equipment provided by the FRS to participants; and number of attendances and reason 
for attendance to participants’ homes by the FRS.     
 
6.6   
Participant withdrawal  
Participants can withdraw from the trial at any point during the course of the study by 
directly contacting the trial coordinator at the YTU or informing a member of the FRS 
delivering the intervention.  However, data collected up to the point of withdrawal will be 
retained for inclusion in the analysis up to the point that the participant informed the study 
team they wish to withdraw.  If a participant indicates that they wish to withdraw from the 
study, they will be asked whether they wish to withdraw from the intervention only (i.e., opt 
not to receive the SWV) or withdraw fully from the study.  Where withdrawal is only from 
the SWV, then follow-up data will continue to be collected.  The reason for the participant 
wishing to withdraw from the study will not have to be stated; however, if the participant 
indicates the reason this will be recorded.   
 
6.7  
Randomisation 
The FRS will notify YTU when they have capacity to deliver SWVs and the number of visits 
they are able to undertake at that time.  Participants who fulfil the eligibility criteria and 
who have provided written consent to take part in the study and returned at least one falls 
calendar within the past three months will be randomised by a member of the research 
team based in the YTU.  Participants will be randomly allocated using the YTU secure web-
based randomisation system designed and maintained by an independent data systems 

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manager at the YTU, who is not involved in the recruitment of participants.  Participants will 
be randomised in a 1:1 ratio to either the intervention or usual care group, using block 
randomisation, stratified by centre. 
 
The YTU will write to the intervention participants informing them of their group allocation 
and that the FRS will be in contact with them to arrange a SWV if allocated to the 
intervention group.  The YTU will notify the FRS that participants have been randomised and 
send them the name and contact details of participants’ requiring a SWV via the University 
of York’s secure DropOff file-transfer system (https://dropoff.york.ac.uk/) or other secure 
method.  The FRS will then contact participants to arrange the SWV.  It is expected that the 
SWV will be delivered approximately three weeks after randomisation.    
 
The YTU will write to the participants’ GPs informing them about their participation in the 
study. 
 
6.8  
Blinding  
Blinding of participants to group allocation in the main FIREFLI trial will not be feasible, nor 
is blinding of the members of the study team who are actively involved in the administration 
of the study, the statistician or health economist.  
 
6.9 
Usual supportive care group  
All participants will receive usual care from their GP and other health care professional(s).  
To describe this care, we will collect health service use data (such as GP attendance; nurse, 
occupational therapist and physiotherapist visits; attendance at falls clinic/services; and 
hospital admissions) via postal questionnaires sent to participants at baseline, and at four, 
eight and 12 months post-randomisation.  All participants will be sent a falls prevention 
leaflet, produced by Age UK, with the baseline questionnaire.  Participants will be sent a 
newsletter at three, seven and 11.5 months to inform them about study progress and 
encourage retention in the trial.  We have found, in an embedded RCT, that using such a 
newsletter increased response rates to postal questionnaires in a similar population (17).  
To further increase response rates to the postal questionnaires, all participants will receive 
an unconditional £5 with their 12 month questionnaire as this has been demonstrated to be 

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an effective strategy (18).  (In order not to coerce participants, no mention of the £5 will be 
made in the participant information sheet.)  Participants randomly allocated to the control 
group will be offered a SWV when their participation in the study has ended.  If, however, 
during the course of the study the FRS evaluate a household as being high risk, and in need 
of a SWV earlier than in accordance with the trial protocol this will be permitted.   
 
6.10  
Intervention group 
Participants allocated to the intervention group will receive usual care from their GP and 
other healthcare professionals.  Health service use data will be collected in the same way as 
detailed in the control group section above.  They will also receive the same falls prevention 
leaflet, newsletters and unconditional £5 with their 12-month questionnaire.  In addition, 
they will be offered a SWV at their home within approximately three weeks after being 
randomised. 
 
The aim of the SWV is to reduce fire risks, support independent living, help prevent 
avoidable hospital admissions and excess winter deaths, and contribute to improving quality 
of life for older people living in England. 
 
A firefighter, day duty safety advocate or Safe and Well Officer will deliver the SWV at a day 
and time convenient to the participant.  The FRS will endeavour to deliver the SWV within 
the home.  However, this may not be possible in all cases, for example due to the need to 
comply with either national or local public health guidance (with respect to the potential 
impact of COVID-19 or as a result of a local outbreak).  In such cases, part or all of the SWV 
may be delivered over the telephone.  A risk based approach to working in the home setting 
will be undertaken in accordance with local FRS procedures, with attempts to minimise the 
amount of time spent within the home.  For example, participants may be asked about 
travel abroad. In cases, where there is high COVID-19 vulnerability, then a triage process 
may be used, through telephone calls and doorstep questioning (with PPE and social 
distancing). Such steps are required to ensure the potential benefit of the SWV are balanced 
against the risk to staff and the public of transmission of the COVID-19 virus.   
 

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The telephone call will aim to mirror the actual SWV as far as possible.  It is anticipated that 
the phone call may take around 20 minutes to complete, and this will be made clear to the 
participant at the start of the call.  The FRS will ask the same questions over the telephone 
as they would in person.  The normal SWV form will be used to record the telephone call 
and the customer records management system will be updated with the information.  The 
FRS will follow local and/or national guidance on how such telephone calls should be 
conducted.  
 
Where a home visit is possible, the visit will last for approximately one hour.  If applicable, 
participants will be informed in the participant information sheet (and at the start of the 
visit if applicable) that the visit may be carried out by a firefighter who is operational, so 
they may be called away at a moment’s notice.  If this happens then the participant will be 
contacted to arrange another date and time to complete their visit if needed.     
 
In addition to the assessment of fire risk, there are four additional key elements to the SWV: 
falls prevention; smoking cessation; social isolation (this element is covered by Humberside 
FRS but not Kent FRS); and cold homes.  Delivery of the SWV between the two FRS varies 
slightly, however, the SWV will be delivered in each area, as per usual practice.  For each 
appropriate element, a risk assessment is conducted and, if appropriate, an intermediate 
intervention is undertaken with referral to specialist help in line with their routine practice.  
Individual FRS have produced their own SWV checklists, and these will be used to deliver the 
SWV and to record what elements of the SWV were delivered to each individual participant. 
 
6.10.1 Fire safety issues  
The firefighter, day duty safety advocate or Safe and Well Officer will undertake a person-
centred fire risk assessment by talking to the participant and taking into account the person 
factors (age, health, mobility, cognitive ability, hearing, etc.), home factors (building 
construction, fire detection, shared spaces, escape routes etc.) and behaviour factors 
(smoking, testing of alarms, closing doors at night, etc.). Advice and interventions will be 
provided on the following: smoke alarms (type, number, location and testing), kitchen and 
cooking safety, safe use of candles, electrical fire safety, fires and heaters safety, clutter and 
hoarding, smoking safety, escape planning (including mobility) and safeguarding.  

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6.10.2 Falls prevention 
Delivery of the falls prevention element of the SWV varies slightly between the two FRS.  
Each FRS will deliver this element according to their usual practice.  This may include: a 
record of health conditions; dementia; mental health; information about number of 
medications; history of falls; balance issues; conditions limiting mobility; fear of falling; 
ability to get out of a chair; ability to undertake exercises; removal of trip hazards; use of 
mobility aids is reinforced and footwear advice; a falls prevention booklet and falls service 
leaflet may be given out; reminder to have flu jab; onward referral to falls service or 
occupational therapists or postural stability services.   
 
6.10.3 Smoking cessation 
An assessment of smoking practices; Use of the Making Every Contact Count (behaviour 
change approach); referral on to stop smoking services; provision of fire retardant bedding 
and other equipment, if required, will be undertaken.    
 
6.10.4 Social isolation 
Living arrangements, assistance from carers and assessment of social isolation will be 
undertaken in the FRS that routinely deliver this.  (Currently this is assessed in Humberside 
FRS.) 
 
6.10.5 Cold homes and housing conditions 
Depending on the time of year of the SWV, room temperature will be discussed; advice 
about financial schemes and how to keep the home warm and safe use of heating 
appliances will be conducted; a thermometer may be provided where necessary and a 
winter wellness advice booklet will be given out.  
 
Any concerns about housing conditions including heating, damp, vermin infestations, and 
unsafe electrical systems will be identified and advice given. Where appropriate, referrals to 
other agencies including local authorities will be made. 
 

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6.11  
Training for clinicians delivering the trial treatment 
Training in how to deliver the SWV will not be required as the FRS will be delivering the SWV 
in accordance with their usual practice.  Relevant training in day-to-day trial management 
activities will be provided to appropriate members of the FRS by the trial team at YTU.   
 
7. 
 Data collection  
 
7.1   
Quantitative data collection  
Participants will be asked to return monthly falls calendars to document whether or not 
they have had a fall in the past month.  Any participant reporting a fall will either be 
telephoned or sent a follow-up questionnaire in the post to collect information about the 
cause/reason for fall, consequence of fall e.g. superficial wound (bruising, sprain, cut, 
abrasions), fractures (including type of fracture), and hospital admissions.    
 
Participants will be asked to complete follow-up questionnaires sent in the post at four, 
eight and 12 months post-randomisation.  Participants who do not return their follow-up 
questionnaire within two weeks will be sent up to two reminder letters plus a copy of the 
questionnaire by post followed by a telephone call two weeks later.  
 
All participants will be sent three newsletters about the trial progress at three and seven 
months post-randomisation, and two weeks before their final 12 month questionnaire is 
due to be sent out.  They will be sent an unconditional £5 with the 12 month questionnaire 
in recognition of their commitment to the study and to cover any expenses incurred in 
completing the questionnaires.  Members of the research team may also contact 
participants or their delegated contact as documented on the consent form, by telephone, 
post, email or text regarding any queries they may have in relation to the follow-up 
questionnaires or falls calendars. 
 
The YTU will manage the questionnaire and case report form (CRF) data in accordance with 
the YTU’s Standard Operating Procedures.  Paper CRF/participant questionnaires will be 
scanned and processed by data management staff.  This will include cross checking data 
against the hard copy of the CRF.  Quality control will be applied at each stage of data 

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handling to ensure that all data are reliable and have been processed correctly.  The trial 
coordinator/manager and statistician will write a Validation Plan for the CRFs in consultation 
with the YTU Data Manager.  The plan will include detailed coding for the CRFs and data query 
resolution rules/procedures.   
 
7.2  
Mixed methods process evaluation 
7.2.1  Implementation, fidelity and acceptability of interventions: 
To address important issues of fidelity and acceptability of the SWV, the following qualitative 
and quantitative data will be collected: 
(i) 
Observations of those delivering the service using a checklist developed specifically to 
record aspects of intervention delivery.  The checklist will include all aspects identified 
as key components to falls prevention as part of the wider SWV.  Up to 25 firefighters 
and day duty safety advocates, selected at random, from the Humberside FRS and all 
of the Safe and Well Officers from Kent FRS will be observed delivering the 
intervention on at least one occasion during the trial period (by author Shelley 
Crossland).  We will aim to observe the delivery of the intervention to participants 
from a range of age, gender and deprivation backgrounds.  
(ii) 
An intervention delivery inventory will be completed for all trial participants detailing 
exact elements of the intervention as delivered. 
(iii) 
Outcome questionnaires (at four, eight and 12 months) will include information on 
adherence with the intervention and/or recommendations made by SWV relating to 
key elements of falls prevention. 
(iv) 
Interviews with trial participants from the intervention arm (approximately n =32 (37)) 
will be conducted.  We will ascertain the acceptability of the intervention and how the 
participants incorporated the suggested changes into their everyday lives and whether 
the SWV had any effect on the wider household.  Interviews will be conducted face-to-
face, over the telephone or via online video calls according to the preferences of each 
interviewee.  We have set out the proposed sampling frame in the table below to 
ensure maximum variation according to gender, age and social deprivation.  The 
sampling frame for each site (Humberside and Kent FRS) would be: 
                                                                                                                                                                     

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Women 
Men 
 
Younger 
Older 
Younger 
Older 
Deprivation* low 
2 
2 
2 
2 
Deprivation high 
2 
2 
2 
2 
*deprivation score to be based on home post code http://imd-by-
postcode.opendatacommunities.org/), educational level and the Mosaic geodemographic 
classification of households (collected and used by the FRS).  These would be selected at 
random from trial participants in the intervention group who have agreed to be 
contacted.  Whilst we have suggested two participants per cell in the sampling frame, it is 
important to note that early data analysis will run concurrently with further data 
collection to allow for an element of flexibility according to a pragmatic definition of data 
saturation. 
 
(v) 
Interviews with firefighters/day duty safety advocates/Safe and Well Officers 
(approximately n=15-20) (37) will be conducted.  Participants will be purposively 
sampled to ensure maximum variation on the basis of staff type, years of experience 
and those who have undertaken many or only a few trial appointments.  Information 
will be collected on their experience of delivering the service, views on whether it is 
fit for purpose, how they interface with other service providers and to highlight 
challenges/facilitators associated with service delivery. 
(vi) 
Interviews with service leaders (n=10) from key stakeholder groups (e.g. fire service, 
social care services, primary care services, falls prevention services) who are involved 
in the design and implementation of the service will be conducted at two time 
points: during project set up to discuss current provision and at the end of the trial 
period to discuss incorporating trial findings into service development. 
 
We will use the FRS contacts within the NHS trusts of the areas they cover and other 
organisations to identify potential service leads to interview.  Kent FRS have  
identified the following organisations, that may be approached:  Medway 
Community Healthcare, Kent Community Health Trust, Medway CCG, Kent Public 

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Health Observatory, SECamb,  Medway Public Health, Kent County Council Public 
Health, Kent County Council, and Age UK.   
 
Humberside FRS have close working relationships with the Integrated Care Centre at 
the Jean Bishop Centre in Hull.  Other trusts covered in their area include: Humber 
Teaching NHS Foundation Trust, City Health Care Partnership – Hull.  We may seek 
local R&D departments assistance to identify individuals who could be interviewed.  
The study has been adopted by the CRN, and so we could also ask for their help in 
identifying potential interviewees.   
 
 
This mixed methods process evaluation will be examined according to a revised version of 
the Carroll et al. conceptual framework for implementation fidelity (38) as outlined in the 
table below:  
 
Fidelity component  
Data utilised 
Context 
Current delivery of SWV. 
Reasons for the introduction of SWV to the fire 
service. 
Integration of SWV with existing health and social 
care provision. 
Initial interviews with service leaders 
Coverage/Recruitment 
What proportion of the target group participated 
in the intervention? 
What recruitment procedures are used, and 
potential barriers to participation/maintaining 
involvement? 
Broad socio-demographic quantitative data 
on non-responders and decliners. 
Interviews with service delivery staff. 
Initial interviews with service leaders.  
Evaluation of adherence 
Was each intervention component implemented as 
planned, correct frequency/duration, appropriate 
quality? 
Observations. 
Intervention delivery inventory. 
Interviews with firefighters/day duty 
advocates. 
Participant responsiveness 
How engaged were participants with SWV? 
Relevance of, and satisfaction, with SWV. 
Perception of outcomes associated with SWV. 
Response to the recommendations made. 
Interviews with participants. 
Outcome questionnaires. 
Interviews with firefighters/day duty 
advocates. 
Intervention complexity/comprehensiveness 
How complex is the intervention? 
How specific is the description of the intervention? 
Initial interviews with service leaders. 
Assessment by study steering group. 

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Fidelity component  
Data utilised 
Strategies to facilitate implementation 
How was the intervention supported? 
Perceptions of challenges to implementation. 
Initial interviews with service leaders. 
Interviews with firefighters/day duty 
advocates. 
 
To inform how the trial findings may be incorporated into developments in service delivery 
of SWV we will draw on data from the second stage interviews with service leaders.  Main 
trial findings on the effectiveness and cost-effectiveness of the SWV on falls prevention and 
health-related quality of life will be discussed and how these findings, combined with those 
on implementation fidelity, can be incorporated into future service planning. 
 
7.2.2  Qualitative analysis 
Qualitative interviews will be audio-recorded and transcribed verbatim.  We will use NVivo 
software to assist our organisation of the qualitative analysis.  To achieve a systematic 
approach to data analysis we will conduct Framework analysis (39) (using the broad 
categories as described in the implementation fidelity model) engaging in: detailed 
familiarisation; identification and indexing of key themes; contextualising these themes in 
relation to the broader dataset; and interpreting them with a focus on addressing the 
specific questions in each phase of the research. 
 
7.3 
Study within a Trial (SWAT) 
RCTs are the key stone of evidence-based healthcare.  However, trial teams often 
experience difficulties in recruiting and maintaining follow-up and questionnaire response 
rates from participants, which can introduce bias, reduce the sample size and statistical 
power, and affect the validity, reliability and generalisability of findings. 
 
There is therefore a need to develop and test interventions to improve recruitment and 
retention of participants.  One method is to ‘embed’ trials of recruitment and retention 
interventions in ongoing RCTs.  Testing interventions in ongoing trials ensures causality of 
intervention effectiveness is assessed and avoids limitations associated with testing in a 
quasi-randomised controlled trial, or non-randomised setting such as the feasibility of 
intervention implementation.  These embedded trials are often referred to as a Study 
Within a Trial (SWAT). 

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The FIREFLI trial will act as a host trial for a SWAT that aims to study an intervention to 
improve recruitment and a further SWAT to improve retention.  The protocol for these 
SWATs can be found in Appendix 1. 
 
8  
Statistical considerations 
 
8.1 
Sample size 
In order to more holistically evaluate the SWV, we have specified two primary outcomes 
(number of falls and EQ-5D-5L) to consider the overall impact on participants’ health and 
quality of life.  The primary research question is formulated so that the ‘success’ of the 
intervention is defined as showing an effect on either (as opposed to both) primary 
outcome; hence, the p-value has been corrected for multiple testing and the two outcomes 
will be tested at the 0.025 significance level.    
  
Approximately a third of people over the age of 65 years and half of those over 80 will fall 
each year (5-7).  We will recruit and randomise 1156 participants in a 1:1 ratio (i.e., 578 to 
control and 578 to intervention).  This number allows for 10% attrition and provides 90% 
power (using two-sided significance at the 2.5% level) to show a difference in the 
percentage of participants who experience at least one fall in the 12 months following 
randomisation from 35% in the control group to 25% in the intervention group (StataCorp. 
2013.  Stata Statistical Software: Release 15. College Station, TX: StataCorp LP).  The primary 
falls outcome is actually a count variable (number of falls, whilst proportion of participants 
experiencing at least one fall over the 12 months is the key secondary outcome); however, 
powering a trial for count data is complex and requires greater assumptions and so a binary 
approach to the sample size calculation was taken for the funding application.    
 
Since funding was awarded, some members of the research team have completed the 
REFORM and OTIS trials of falls prevention interventions in similar (older, community-
dwelling) populations, using falls calendars to collect number of falls over 12 months, 
analysed using a negative binomial regression model.  We can therefore use data from 

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these trials to estimate the minimum difference we may be able to detect in this trial.  In 
REFORM, we observed a mean predicted falls rate per person, over 12 months, of 1.66 in 
the usual care group and 1.45 in the intervention group (incidence rate ratio of 0.88).  The 
dispersion parameter from the negative binomial regression model was estimated at 1.34.  
In OTIS, we observed a mean predicted falls rate, over 12 months, of 1.76 in the usual care 
group and 2.05 in the intervention group (incidence rate ratio of 1.17).  The dispersion 
parameter was estimated at 1.29.  We estimate that, assuming a falls rate in the usual care 
group of 1.7 and a dispersion parameter of 1.3, with 1156 participants (1:1 allocation) we 
will have 90% power to detect a 25% decrease in falls (two-sided 2.5% significance). 
 
This sample size will also provide ample power for the analysis of the EQ-5D-5L.  Assuming a 
more generous attrition rate of 20%, recruiting 1156 participants would give us 90% power 
to detect an effect size of 0.23, using two-sided significance at the 2.5% level.  In the 
REFORM trial, the baseline standard deviation (SD) for the EQ-5D-3L index value was 0.24 
and in the OTIS trial, where the 5-level version was used, it was 0.20.  Assuming this range of 
SD, a standardised effect size of 0.23 equates to a difference in EQ-5D index value of 0.046 
to 0.055.  Walters and Brazier (22) in a review paper of the EQ-5D-3L found a difference of 
0.074 (mean) or 0.081 (median) to be a minimum clinically important difference (MCID) 
among a variety of patients, whilst McClure and colleagues found a difference of 0.063 
(mean) or 0.064 (median) for the EQ-5D-5L using simulated data (23).  These estimates of 
the MCID are greater than the likely difference we are powered to detect and so the sample 
size will be conservative for the EQ-5D-5L analysis.    
 
8.2 
Statistical analysis for the main FIREFLI trial  
There will be one single analysis at the end of the trial.  All analyses will be conducted in 
Stata v15 or later (StataCorp, 4905 Lakeway Drive, College Station, Texas 77845 USA).  
Analyses will be described in detail in a Statistical Analysis Plan drafted by the study 
statisticians and reviewed by the Trial Steering and Monitoring Committee.  It will be signed 
off by the Chief Investigator and the study statisticians prior to the analysis being 
undertaken.  The main planned analyses are summarised below. 
 

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All analyses will be conducted following the principles of intention-to-treat with 
participant’s outcomes analysed according to their original, randomised group, where data 
are available, irrespective of deviations based on non-compliance.  Two sided tests at the 
2.5% significance level will be used for the primary outcomes, and at the 5% level for the 
secondary outcomes.   
 
The trial will be reported according to the CONSORT guidelines for clinical trials 
(Consolidated Standards Of Reporting Trials statement, http://www.consort-
statement.org/).  Baseline data (sex, age, diagnosis distributions, etc.) will be summarised 
descriptively by trial arm and presented in tabular form.  Continuous measures will be 
reported as means and standard deviations whilst the categorical data will be reported as 
counts and percentages.  No formal statistical comparisons will be undertaken on baseline 
data.   
 
8.3 
Primary outcome for the main FIREFLI trial  
The number of falls per person will be analysed using a negative binomial regression model 
adjusted for gender, age, history of falling, and site (Kent or Humberside), to estimate the 
difference in falls rate between the groups.  The model will include an exposure variable for 
the number of months that the participant returns a monthly falls calendar.  The point 
estimate for the treatment effect in the form of an incidence rate ratio (IRR) and its 
associated 95% confidence interval (CI) and p-value will be provided.    
 
EQ-5D-5L index value will be analysed using a covariance pattern model incorporating all 
post-randomisation time points and adjusting for baseline score, gender, age, history of 
falling, site, treatment group, time and a treatment group-by-time interaction.  The 
correlation of observations within participants over time will be modelled, using participant 
as a random effect.  The Akaike information criterion will be used to compare models 
specifying different correlation structures (smaller values preferred).  The adjusted mean 
difference and its associated 95% CI and p-value will be extracted for each individual time 
point and overall.  The estimate over the whole 12 months will serve as the primary 
endpoint while the differences at four, eight and 12 months will serve as secondary 
endpoints. 

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8.4 
Subgroup analyses  
We will include a subgroup analysis for the primary outcome based on socioeconomic status 
(e.g. deprivation index (IMD) assessed via home post code http://imd-by-
postcode.opendatacommunities.org/), educational level and the Mosaic geodemographic 
classification of households (collected and used by the FRS).  In order to find out 
participant’s education level, we will ask them a single question.  They will select one option 
from the following categories: no formal qualification; qualification relating to clerical work 
or a trade; formal school qualification at 16 years (O level/CSE/School Certificate); formal 
school qualification at 18 years (A level/Higher school certificate) or above.  We have 
included the option of school certificate as this is a qualification relevant to this population.   
These data will be used to produce a deprivation index score that will also be used in the 
qualitative sampling strategy.  
 
8.5  
Sensitivity analyses  
Sensitivity analyses for the primary outcomes will be conducted to consider the effect of 
clustering by firefighter day duty safety advocate or home safety Safe and Well Officer.   
 
8.6 
Missing data 
We anticipate that missing data for the statistical analysis will be relatively small.  The 
amount of missing data will be reported for each randomised arm, and we will also compare 
the baseline characteristics of participants who are included in the primary analysis to 
ensure that any attrition has not produced any imbalance in the groups in important 
covariates.  To account for any possible selection bias, a logistic regression will be run to 
predict non-response (no falls data received post-randomisation) including all variables 
collected prior to randomisation.  The primary analysis will then be repeated including as 
covariates all variables found to be significantly predictive of non-response to determine if 
this affects the parameter estimates. 
 
8.7 
Intervention adherence  
Complier Average Causal Effect (CACE) analyses to assess the impact of compliance on 
treatment estimates will be undertaken for the primary outcomes.  CACE analysis allows a 

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treatment estimate of, in this case, a SWV by a firefighter, day duty safety advocate or Safe 
and Well Officer in the presence of non-compliance.  It is less prone to biased estimates 
than the more commonly used approaches of per protocol or ‘on treatment’ analysis as it 
preserves the original randomisation and uses the randomisation status as an instrumental 
variable to account for the non-compliance. 
 
8.8 
Secondary outcomes for the main FIREFLI trial  
8.8.1 Proportion of participants falling, experiencing a fracture or fear of falling  
The following secondary outcomes will be analysed by logistic regression adjusting for 
gender, age, history of falls, and site as in the primary analysis: 
 
 
Proportion of participants who fall at least once over the 12 months from the date 
of randomisation  
 
Proportion of multiple fallers (two or more falls) in the 12 months from 
randomisation 
 
Proportion of participants having at least one fracture over the 12 month follow-up 
 
Proportion of participants obtaining multiple fractures (from different events, if this 
occurs a sufficient number of times) over the 12 month follow-up 
 
Proportion of participants who report that they are worried about falling at least 
some of the time at 12 months post-randomisation 
 
Odds ratios and their associated 95% CI and p-value will be provided. 
 
8.8.2 
Time to fall 
The time to the first fall will be derived as the number of days from randomisation until the 
patient reports having a fall as detailed on the participant’s falls calendar, falls data 
collection sheet or self-reported questionnaire.  Time between any subsequent falls will also 
be calculated.  Participants who do not have a fall will be treated as censored at their date 
of trial exit, date of last available assessment or 365 days/trial cessation, as appropriate.  
The proportion of patients yet to experience a fall will be summarised by a Kaplan Meier 
survival curve for each group.  Time to fall will be analysed using the Andersen and Gill 
method for analysing time to event data when the event can be repeated.  The analysis 

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treats each time to event or censoring as a separate observation.  The data will be analysed 
by Cox Proportional Hazards regression using robust standard errors to account for 
dependent observations by participant, and adjusting for gender, age, site and history of 
falling.  The hazard ratio, 95% CI and p-value will be provided.  The proportional hazards 
assumption will be evaluated using Schoenfeld residuals.  
 
8.8.3 
 Fear of falling, loneliness and fire risk score  
Fear of falling (in its continuous form), the loneliness scale and fire risk score will all be 
analysed using a covariance pattern model as described for the EQ-5D-5L index values.    
 
8.8.4  
Flu jab, smoking outcomes  
Uptake of the flu jab and smoking outcomes (e.g. whether any resident of the household 
smokes, and whether smoking is permitted inside the property) will be analysed using 
logistic regression adjusting for gender, age, history of falls, and site as in the primary 
analysis. 
 
8.8 
Economic analysis  
The cost-effectiveness of the SWV versus usual care will be assessed via a within-trial 
economic evaluation, which will comprise a cost-utility analysis and cost-effectiveness 
analysis.  The analyses will be conducted on an intention-to-treat basis using patient-level 
trial data and data sourced from the FRS.  Health-related quality of life, based on the EQ-5D-
5L(34), will be used as the outcome measure for the cost-utility analysis.  A cost-
effectiveness analysis will also be undertaken to explore findings in terms of falls 
prevention, with a cost per fall averted being generated.   
 
Health benefits and cost data will be collected over a follow-up period of 12-months, with 
costs presented in UK £ for the appropriate year.  Discounting of costs and outcomes will 
not be required due to the time horizon not exceeding 12 months.  The base case analysis 
will be undertaken from the societal perspective, with a secondary analysis capturing the 
perspective of the NHS and personal social services.  The analysis will be undertaken in Stata 
release v15 (StataCorp, 4905 Lakeway Drive, College Station, Texas 77845 USA) or later and 

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the analysis methods will follow, wherever possible, the recommendations of the National 
Institute for Health and Care Excellence (NICE) reference case (40). 
 
Falls-related costs will be collected via participant self-reported questionnaires (at baseline, 
four, eight and 12 months), by asking participants to record their health care resource use 
within primary care and the community (i.e. visits to the GP, nurse, occupational therapist 
and physiotherapist) and secondary care (i.e. inpatient nights spent in hospital, day case 
attendances, outpatient attendances, and accident and emergency admissions).  In order to 
capture the broader impact we will collect further information in addition to health care 
costs, such as information regarding participants’ time and expenses (i.e. travel costs for 
appointments, additional equipment), and informal care provided by family/friends, 
including productivity losses.  
 
The cost of the SWV intervention will be estimated using information collected from the 
FRS, such as the time spent at the visit (including for the falls prevention component) and 
the cost of equipment provided by the FRS to participants.  Unit costs will be obtained from 
established costing sources wherever possible, such as NHS Reference Costs (41) and PSSRU 
Unit Costs of Health and Social Care (42), and applied to the resources used to provide an 
estimate of the total cost per participant.  The opportunity cost of the time spent by FRS 
personnel on the SWV will also be explored and described, by estimating the costs of 
alternative uses of the FRS.  Such opportunity cost data will be obtained from surveys of FRS 
personnel. 
 
The EQ-5D-5L will be used to derive utilities for the estimation of quality-adjusted life years 
(QALYs).  The current NICE guidance available at the time of analysis will be followed 
regarding the value set to use for the EQ-5D-5L.  QALYs will be generated using the area 
under the curve approach (43).  Regression methods will be used to calculate mean within-
trial estimates of costs and health benefits, allowing for the correlation between costs and 
benefits, and adjusting for covariates.  Missing data will be dealt with using multiple 
imputation methods (44) in the base case, with a complete case analysis explored through 
sensitivity analysis. 
 

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Mean costs and effects will be estimated for both groups (i.e. the intervention and usual 
care) and findings will be presented in terms of incremental cost-effectiveness ratios; 
specifically, the incremental cost per QALY gained and the incremental cost per fall averted.  
Net health benefit will also be used to represent the findings (45).  Sensitivity analyses will 
investigate the impact of underlying assumptions of the analysis and key cost drivers in 
terms of the cost-effectiveness results.  The uncertainty around the decision to adopt the 
SWV for falls prevention and improve well-being will be represented by cost-effectiveness 
acceptability curves (46), which will depict the probability of the SWV being cost-effective 
for different willingness-to-pay (per QALY) thresholds.  Analyses will be detailed in a pre-
specified health economics analysis plan written by the trial’s Health Economist, reviewed 
by the TSC/DMEC and signed off by the Chief Investigator. 
 
8.9 
Definition of the end of the trial  
The end of the study is defined as the date when the last randomised participant is due to 
return their 12 month follow-up questionnaire.  The trial will be stopped prematurely if: 
 Funding for the trial ceases; 
 Mandated by the Research Ethics Committee; or  
 Following recommendation from the Trial Steering/Data Monitoring and Ethics 
Committee.  
 
The Research Ethics Committee will be notified in writing if the trial has been concluded or 
terminated early.  
 
9. Adverse Event Reporting  
 
9.1  
Adverse Events  
In the context of this study, we will record and report only details of any serious adverse 
events (SAEs) that are required to be reported to the Health Research Authority (HRA) i.e., 
events which are related to an aspect of taking part in the study and are of an unexpected 
occurrence.  Non-serious adverse events will only be recorded and reported for this study if 
the event is related to being in the study or is related to the intervention.   

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Details of any SAEs reported to the YTU either directly by the participant or by a member of 
the FRS will be recorded using a trial adverse event form.  Events reported by the FRS should 
be reported to the YTU within 48 hours of them becoming aware of the event.  Once 
received, causality and expectedness will be confirmed by the Chief Investigator.  A follow-
up report will be completed if additional information becomes available.    
 
The most common Adverse Event (AE) likely to occur within the study relates to falls, which 
are being recorded (in patient self-reported falls calendars and follow-up questionnaires) as 
part of the trial.  If a participant has a fall, an AE form will only be completed if the 
consequence is serious and unexpected.    
 
9.2  
Definition of Serious Adverse Events  
For this trial, a Serious Adverse Event (SAE) is defined as any untoward occurrence that:  
 
(a) Results in death  
(b) Is life threatening  
(c) Requires hospitalisation or prolongation of existing hospitalisation  
(d) Results in persistent or significant disability or incapacity 
(e) Consists of a congenital anomaly or birth defect  
(f) Is otherwise considered medically significant by the investigator. 
 
9.3  
Expected Adverse Events and expected side effects  
Incidents of hospitalisations, disabling / incapacitating / life-threatening conditions, aging-
associated diseases (such as cancer, cardiovascular disease, diabetes, arthritis, osteoporosis, 
dementia), other common illnesses such as depression, falls and deaths are expected in the 
study population due to the age of the cohort.  Similarly, any hospitalisation that was 
planned prior to entry into the study or cannot be attributed to taking part in the study or 
prolongation of an existing hospitalisation due to social reasons will not be recorded as a 
SAE.  A pre-existing condition (i.e., a disorder present at the start of the study) will not to be 
reported as an AE.   An ‘unexpected event’ is defined as a type of event not listed in the 
protocol as an expected occurrence.   

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9.4  
Definition of a related adverse event 
An event is defined as ‘related’ if the event was due to the administration of any research 
procedure as detailed in the current regulatory approved protocol.  The relatedness of an 
event will be reviewed by the Chief Investigator and another member of the Trial 
Management Group and the Trial Steering/Data Monitoring and Ethics Committee. 
 
9.5 
Reporting period   
The AE reporting period for this trial begins as soon as the participant consents to be in the 
study and ends 12 months after they are randomised.  For those participants who are not 
randomised, the reporting period will end once the participant is informed that their 
participation in the study has ended.  
 
10.  
Trial monitoring  
 
10.1  Site monitoring 
Site monitoring visits for this study will not be undertaken on behalf of the sponsors with 
the following justification: 
(a) The eligibility for the study is undertaken by review of potential participant’s self-
reported data by researchers based at the YTU 
(b) Consent is taken via the post  
(c) The majority of source data for this study is patient self-reported via questionnaires 
or falls calendars 
(d) Data on adverse events will mainly be collected via participant self-report data sent 
to the YTU.  However, if a member of the FRS becomes aware that an adverse event 
has occurred, then they will report this to the YTU using an Adverse Event Form. 
 
Participating sites may be asked to assist in trial related monitoring when required, for 
example audits, ethics committee review and regulatory inspections. 
 

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10.2 
 Standard Operating Procedures 
The study will be run in accordance with the York Trials Unit’s (Health Sciences, University of 
York) Standard Operating Procedures and with the FRS’s data protection policies.   
 
11.  
Public Involvement and Engagement (PIE) 
Public involvement and engagement input has played a part in shaping this study at the 
grant application stage, and will continue to be at the heart of the trial going forward.   
 
We will establish a Public Involvement and Engagement (PIE) group.  It is anticipated that 
the group will consist of five men and women over the age of 70 years who have fallen and 
will meet approximately four times during the course of the study, at a date and time 
convenient to the group and at key points of the study.  We anticipate that during the 
course of the study some members of the group will leave.  If this is the case we will recruit 
additional members.  Members of the PIE will be sought from the OTIS trial, Humberside 
and Kent older people user groups, people in the research website 
(https://www.peopleinresearch.org/) or from the local Age UK or other local groups 
attended by older people.  We may also advertise for members. 
 
The group will provide input into, and feedback on, study documents including the protocol, 
patient information sheets and consent forms, questionnaires, contents of the newsletters 
and plain English summaries of the findings.  We anticipate that they will also assist with 
disseminating the study findings to the public.  In addition, we will invite at least one 
member of the PIE group to join the joint Trial Steering Committee/Data Monitoring and 
Ethics committee.   
  
12.  
Ethical issues  
We are aware that some older people may represent a vulnerable group.  We will conduct a 
risk assessment, which will include an assessment of potential safeguarding issues, which 
could potentially arise within the day-to-day running of the study.  The FRS, person 
undertaking the fidelity observations and members of the research team based in the YTU will 
work to their local safeguarding procedures.    Participation in the study is voluntary.  

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Participants will be able to withdraw from the study at any point without prejudice by 
contacting the trial coordinator.  
 
Confidentiality Advisory Group (CAG) approval will be required to gain access to the data 
held by the FRS.  Therefore, an application for Health Research Authority (HRA) and 
Research Ethics approval will be sought.   
 
12.1  Protocol amendments 
Any amendments to the protocol during the course of the trial will be submitted for 
approval by the REC/HRA as necessary. 
 
12.2  Legal bases of processing data  
Notwithstanding the above, personal data and special category personal data will be 
processed in connection with this study under the legal bases of Article 6(1) (e) and Article 
9(2) (j) of the General Data Protection Regulation (GDPR), respectively for processing for the 
performance of a task carried out in the public interest, and as necessary for archiving 
purposes in the public interest, scientific or historical research purposes or statistical 
purposes, with Article 9(2) (j) operating in conjunction with the safeguard requirements set 
out in Article 89(1) of the GDPR. 
 
12.3 
Anticipated risks and benefits 
This study does not involve any invasive/potentially harmful procedures and is therefore 
considered low risk for participants.  The trial intervention is the same as the SWV currently 
being delivered by the FRS within the recruitment area so we do not anticipate any 
additional risks or potential harms above that experienced in routine practice  
 
12.4  Informing participants of anticipated risks and benefits  
The participant information sheet will provide information about the possible benefits and 
anticipated risks of taking part in the study.  Participants will be given the opportunity to 
discuss participation with the study team at the YTU prior to consenting to participate.  In 
the unlikely event that new information arises during the trial that may affect participants’ 

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willingness to take part, this will be reviewed by the TSC/DMEC for addition to the patient 
information leaflet.  A revised consent form will also be completed if necessary. 
 
12.5 
Retention of study documentation  
All data will be stored for a minimum of ten years after the end of the main analysis of the 
trial in accordance with the current YTU’s Standard Operating Procedures.  All paper records 
will be stored in secure storage facilities.  Personal identifiable paper records will be stored 
separately from anonymised paper records.  All electronic records will be stored on a 
password protected server within the YTU or on the University of York approved cloud.  
 
Electronic data stored at the YTU will be held in a secure environment, with permissions for 
access limited to the study team.  The Department of Health Sciences, in which YTU is based 
at the University of York, has a backup procedure approved by auditors for disaster recovery.  
Full data backups are performed nightly using rotational tapes, to provide five years’ worth of 
recoverable data.  The tape backup sessions are encrypted and password protected, with 
tapes stored in a locked fire-proof safe in a separate secured and alarmed location. 
Additionally , data will be stored securely on the  University of York approved cloud, by 
companies operating within the UK or EU offering ‘cloud’ based services. The University of 
York has signed up to the EU model clauses to ensure compliance with GDPR ( 
https://cloud.google.com/security/compliance/eu-mcc ).   All study files will be stored in 
accordance with Good Clinical Practice guidelines.   
 
The separate archival of electronic data will performed at the end of the trial, to safeguard the 
data for the period(s) established by relevant regulatory requirements.  All work will be 
conducted following the University of York’s data protection policy, which is publically 
available (www.york.ac.uk/recordsmanagement/dp/policy. 
 
Essential trial paper documentation, for example participant questionnaires and consent 
forms, will first be archived in the YTU’s archive, and may be moved to an off-site location in 
accordance with YTU’s Standard Operating Procedures.  
 

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12.6  Access to data  
A statement of permission to access source data by study staff and for regulatory and audit 
purposes will be included within the patient consent form with explicit explanation as part 
of the consent process and Participant Information Sheet.  Once the YTU has completed the 
analysis and published all intended papers in scientific journals, the data may be made 
available for other researchers.  Requests for access to data will follow YTU SOPS.    
 
12.7  Confidentiality  
All data collected during the course of the trial will be pseudo-anonymised using a unique 
identifier code, which can be linked back to the participant.  The FRS data manager will 
ensure all routinely collected FRS data is pseudo-anonymised using a unique identifier code 
before being transferred the YTU.  If required, data sharing agreements will be set up 
between the members of the research team.  Participants will be asked to give their consent 
to allow the FRS to share data required for the trial, with the YTU.  Any release of data to 
other research groups will be truly anonymised with the unique identifier stripped away.   
 
All information provided for the purposes of this study will be kept strictly confidential.  
However, if the participant discloses information which would raise concerns about their 
health, (for example during a qualitative interview or a follow-up telephone call), or if in line 
with standard FRS procedure, there is a Safeguarding issue or if there is an interest of public 
safety or prevention of criminal activity, then the researchers will be required to break that 
confidence and inform the participant’s GP or other relevant person/agency.   
 
12.8 
Consent 
 
12.8.1 Consent to the main trial  
Participation in the study will be entirely voluntary.  Potential participants will receive an 
information pack about the trial in the post including a consent form.  Potential participants 
will be given the trial coordinator’s or trial support officer’s telephone number to phone if 
they have any queries about taking part in the study. 
 

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12.8.2 Consent to the qualitative study  
The qualitative researcher will obtain informed consent from the participant for the 
qualitative part of the study.   
 
12.8.3 Consent to the SWAT 
Due to the nature of the intervention of the SWAT, it will not be possible to ask participants 
to give their informed consent to enter either of the SWATs.  We will therefore ask the 
ethics committee to waiver consent for this part of the study only.  We do not consider this 
to be a major ethical issue.  
 
12.8.4 Consent for the observation 
Consent for an occupational therapist (OT) to observe the SWV will be sought from the 
member of the FRS conducting the SWV.  They will be given a Participant Information Sheet  
explaining why the visit is being observed and will be given the opportunity to ask questions.  
They will be asked to sign a consent form to document their agreement to being observed.   
 
Consent will also be sought from the trial participant for the observation.  Verbal consent 
will be obtained during the initial phone call to arrange a home visit.  At this point the 
purpose of the attendance and the fact that the focus will be on the person from the FRS 
delivering the SWV and not the participant will be reiterated.  Written consent will then be 
obtained at the beginning of the home visit.  Participants will be able to decline the OT 
attending the visit at any point during the process, and will still be able to have a home visit.    
 
13.  
Oversight  
13.1 
Sponsorship 
The University of York will act as the sponsor for the study.   
 
13.2  Indemnity 
The University of York will provide insurance for the design of the research as embodied in 
this protocol that shall extend to participating NHS organisations and collaborators where 
conducting procedures in accordance with the protocol.  Non negligent harm will not be 
covered.  The FRS have insurance which covers all legitimate practices within the remit.   

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13.3 
Funding acknowledgement 
Research funding has been secured from the National Institute of Health Research – Public 
Health Research reference 128341.   
 
13.4  Independent Trial Steering and Data Monitoring and Ethics Committee 
Due to the low risk nature of this study, approval from the funders has been given to set up 
one Independent Steering and Monitoring Committee to undertake the roles traditionally 
undertaken by the Trial Steering Committee (TSC) and the Data Monitoring and Ethics 
Committee (DMEC).  The independent members will include the Chair who will be a clinician 
with expertise in falls prevention, a statistician, a health economist, an occupational 
therapist, a member of the patient public group and a member of Age UK.  Dependent 
members will include the Chief Investigator, trial statistician, trial coordinator and a trial 
methodologist based in the YTU.  Other study collaborators may also attend the meeting.  
The committee will adhere to the NIHR terms of reference for TSC and DMEC committees.  
Their role will include the review of all serious adverse events which are thought to be 
treatment related and unexpected.  The committee will meet at least annually or more 
frequently if the committee requests.  
 
13.5  Trial Management Group (TMG) 
A TMG will be set up.  It will consist of the Chief Investigator, the study’s grant co-applicants, 
data managers based in the YTU and delegated person at sites delivering the intervention. 
Regular meetings will be held according to the needs of the trial.  The role of the TMG is to 
monitor all aspects of the conduct and progress of the trial, ensure that the protocol is 
adhered to and take appropriate action to safeguard participants and the quality of the trial 
itself.  The frequency of the meetings will depend on the needs of the trial.       
 
Trial progress will also be reviewed at the YTU’s Trial Coordinator meetings.  These meetings 
are held by the Director of the York Trials Unit approximately every two months.   
 

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13.6  
Disclaimer  
The views expressed are those of the authors and not necessarily those of the NHS, the 
NIHR or the Department of Health and Social Care. 
 
14. 
Publication policy 
The study will provide evidence on the effectiveness and cost-effectiveness of including a 
falls prevention element in the SWV delivered by the FRS to older people and whether the 
SWV improves their health-related quality of life.  We will seek advice from our PIE Group 
and TSC/DMEC to develop a dissemination strategy.  Age UK has agreed to endorse our 
research study and will assist with knowledge transfer and dissemination of study results, if 
the results of the trial show a benefit.  However, it is intended that the study will be 
presented and results disseminated in the following ways: 
 
 A short summary of the results, written in lay language will be produced and sent to 
trial participants.  
 Oral presentations or posters at local, national and international conferences such as 
the PHE Conference, Humberside Safe and Well Conference, the Prevention, 
protection and health conference,the Australian and New Zealand Falls Prevention 
Conference, the Society for Research and Rehabilitation conference, and at regional 
prevention group meetings.   
 Publication in peer-reviewed scientific journals (including the trial protocol), such as the 
Journal of the American Geriatric Society, Age and Ageing,  or Occupational Therapy 
journals such as the British Journal of Occupational Therapy, OT News and OT magazine.  
 The Cochrane falls review group will be sent a copy of the results, which will be 
incorporated into their next update for falls prevention in the community.  
 The funders, the NIHR PHR, currently publish all monographs on their website 
https://www.journalslibrary.nihr.ac.uk/PHR/#/ and it is anticipated that the full trial 
report will be available approximately one year after the final report is submitted.  
 A briefing document about the study and its results will be shared with: the National 
Fire Chief Council (NFCC) committees including the NFCC prevention committee, which 
collaborates with the NFCC health committee on the SWV standard evaluation 

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framework; Public Health England; and Chief Fire Officers for all the FRSs, through the 
NHCC across the UK. 
 The results of the study will be disseminated through PPI representatives, for example 
talks at the University of the Third Age (U3A) and other clubs for older people and 
briefing documents to put in Age UK’s website.    
 Press Offices and Media Relations at the Universities of York, Nottingham and James 
Cook (Australia), and Kent and Humberside FRS will promote the study on their 
webpages and issuing press releases and social media. 
 The content of the Kent and Humberside SWVs will be informed by the results of the 
study and the results will be used in the ongoing development of the SWVs nationally  
 
15. 
Plan of investigation and timetable  
The FIREFLI study was proposed to run from the 1st February 2020 to the 31st January 2023.  
However, due to the COVID-19 pandemic, recruitment to the trial has been delayed.  The 
summarised project plan is provided below.  
 
 
Month 0-6 
Month 7-18 
Month 19-30 
Month 31-36 
Set-up  
 
 
 
 
 
Recruitment 
 
 
 
 
 
12 month follow-up 
 
 
 
 
 
Analysis and write up  
 
 
 
 
 
 
 
16. 
Declaration of interests 
 
Sarah Cockayne declares no conflicts of interest. 
Prof Avril Drummond declares that she is a member and Deputy Chair of the HEE/NIHR 
Integrated Clinical Academic Programme Review Panel   
Prof Catherine Hewitt declared that she is a member of the NIHR HTA commissioning board  
Prof Joy Adamson declares that she is a member of the NIHR HTA commissioning board 
Caroline Fairhurst declares no conflicts of interest.  

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Rachel Cunningham-Burley declares no conflicts of interest.  
Arabella Scantlebury declares no conflicts of interest.  
Alison Pighills declares no conflicts of interest.  
Sarah Ronaldson declares no conflicts of interest.  
Shelley Crossland declares no conflicts of interest.  
Prof David Torgerson declares no conflicts of interest.  
Sarah Wilkinson declares no conflicts of interest.  
Jo Mann declares no conflicts of interest.  
Richard Stanford-Beale declares no conflicts of interest.  
Steve Duffield declares no conflicts of interest.  
 
 
17. 
 List of abbreviations 
 
Abbreviation 
Explanation  
 
AE  
Adverse event  
CONSORT  
Consolidated Standards of Reporting Trials  
EQ-5D-5L 
EuroQol 5 Dimension (5-Level) scale 
FRS 
Fire and Rescue Service  
GP  
General Practitioner  
MCA 
Mental Capacity Act 
NICE 
National Institute for Health and Care Excellence 
NIHR 
National Institute of Health Research 
PHR 
Public Health Research 
PIS 
Participant/ Patient Information Leaflet 
PHE 
Public Health England 
PIE 
Public Involvement and Engagement 
QALY 
Quality-adjusted life year 
SAE 
Serious Adverse Event  
SAP 
Statistical Analysis Plan 
SD 
Standard Deviation 

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Abbreviation 
Explanation  
 
SOP 
Standard Operating Procedure 
SWAT 
Study within a Trial  
SWV 
Safe and Well Visit  
TMG  
Trial Management Group  
TSC/DMEC 
Trial Steering Committee/Data Monitoring and Ethics 
Committee  
YTU  
York Trials Unit 
 
 
18.     Table of protocol changes  
 
Version number  
Date of protocol  
Summary of changes 
1.1 
02.09.2020 
Additional fire taking behaviour items added: 
shutting internatl doors at night; escape plan; 
confidence in escaping safely in the event of a 
fire; how safe the participant feels in their 
home; fire safey knowledge.  
 
2.0 
31 March 2021 
Clarification added at the request of REC 
regarding: the identification of those who are 
unable to give consent; capacity assessment 
process; clarification that for those who have 
withdrawn from the study, their data will be 
used up to the point that they ask to withdraw. 
Additional text added to Sections 5.5.2. and 
5.5.3 and 6.6.  
 
Additional sites where service leads may be 
interview have been added to section 7.2.1. 
  
3.0 
04.05.2021 
REC reference number added.  
 
Duration of recruitment and study updated, 
however, these dates are to be agreed with the 
PHR.   
 
In order to mitigate the effects of COVID-19, 
Safe and Well Visits may partly be delivered over 
the phone in addition to being delivered in the 
participant’s home.  
 

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Name change from Home Safety Officer to Safe 
and Well Officer. 
 
Clarification to the consenting process for those 
without capacity.  
 
Additional locations to advertise for volunteers 
and for prenotification of recruitment invitations 
being sent out. 
 
Change in data flow in the FRS obtaining data 
from NHS  
 
Addition that data will be stored on the cloud.  
4.0 
27.10.2021 
Adding about using Experian data for the 
mailout (pg. 22)  
5.0 
23.05.2022 
Additional eligibility check with the FRS 
regarding direct recruitment in response to 
advertisement, as opposed to recruitment via 
mailout. Need for YTU to check with the FRS the 
potential particpant’s eligibility for a SWV prior 
to being entered into the study by sharing their 
address with the FRS. This requires an additional 
statement on the consent form, modified PIS  
6.0 
29.07.2022 
Reduction of the inclusion age to aged 65 or 
over at Humberside FRS ( reflects their usual 
practice) and changing initial mailout to include 
a shorter Expression of Interest letter,with only 
those interested in taking part/receiving more 
information receiving a full recruitment pack on 
request.  
19. 
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20. 
Appendix 1  
We will undertake two Studies Within A Trial (SWAT) to evaluate the effectiveness of an 
invitation letter based on the principles of Self-Determination Theory (47) on recruitment of 
participants to the FIREFLI study and a pen to increase response rates to postal 
questionnaires.   
 
20.1  Recruitment SWAT  
Self-Determination Theory is a theory of human motivation, and what moves people to act.  
The theory outlines three core needs which facilitate self-determined (autonomous) 
motivation, these include autonomy (having choice), competence (feeling effectant), and 
relatedness (feeling connected to others).  The  invitation letter has been designed, with an 
aim to make people feel (i) they have choice and are pursuing the research because it suits 
one’s values, (ii) they are competent to undertake the study and they could do this well, and 
(iii) that they feel connected to other people taking part.   
 
Participants allocated to the intervention group will be sent an invitation letter informed by 
Self-Determination Theory  with their trial invitation pack whilst control participants will 
receive the ‘standard’ invitation letter used within the YTU to recruit participants via the 
post.  Participants will be randomised using block randomisation with randomly varying 
block sizes in a 1:1 ratio .  The allocation schedule will be generated by a York Trials Unit 
statistician otherwise not involved in the recruitment of participants.     
 
Inclusion criteria  
Any patient identified in the FRS mail out as eligible to receive a FIREFLI trial invitation pack 
will be entered into the invitation letter recruitment SWAT.   
 

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Outcome measure 
The primary outcome will be the proportion of participants who go on to be randomised to 
the FIREFLI trial.   
 
Secondary outcomes include:  
a. Proportion of participants who return a screening form 
b. Proportion of participant who are eligible for randomisation 
c. Proportion of participants who remain in the trial at three months post-
randomisation (defined as returning at least the first three months’ worth of falls 
calendars from the date of randomisation) 
 
Sample size 
As is usual with an embedded trial within a trial, no formal power calculation will be 
undertaken for the study, as the sample size will be constrained by the number of 
participants available to mail out to. 
 
Statistical analysis  
Binary data will be compared using logistic regression. 
 
20.2 
Retention SWAT  
There is some evidence to suggest that including a pen with a postal follow-up 
questionnaire has a positive impact on response rates and number of reminders required.  
In theory including a pen not only facilitates its completion, but also acts as an 
acknowledgement of the participant’s help with the study, making the recipient more likely 
to complete it.  Participants in the FIREFLI trial will be posted a follow-up questionnaire four 
months post-randomisation.  Participants who do not return their follow-up questionnaire 
within two weeks will be sent  up to two reminder letters plus a copy of the questionnaire 
by post followed by a telephone call two weeks later.  
 

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We will undertake an embedded randomised controlled trial in order to evaluate the 
effectiveness of including a pen with the first reminder letter for participants who do not 
return their four month questionnaire within two weeks of it being sent.   
 
Block randomisation, stratified by main trial allocation, with randomly varying block sizes 
will be used to randomise participants to receive a pen or not with their reminder 
questionnaire.  The allocation schedule will be generated by a York Trials Unit statistician 
otherwise not involved in the recruitment or follow-up of participants. 
  
Inclusion criteria  
For logistical reasons, all participants due to be sent a four month questionnaire will be 
randomised into the SWAT.  However, only those sent a four month questionnaire reminder 
letter will be included in the analysis.   
 
Exclusion criteria  
Participants who withdraw from follow-up before their four month questionnaire is due and 
those for whom it is not necessary to send a reminder letter will be excluded from the 
SWAT.   
 
Outcome measures 
The primary outcome will be the proportion of participants in each SWAT group who return 
the questionnaire.  Secondary outcomes will include time to response (length of time taken 
to return the questionnaire), and completeness of response (the number of questions 
completed).   
 
Sample size 
As is usual with an embedded trial within a trial, no formal power calculation will be 
undertaken for the study, as the sample size will be constrained by the number of 
participants in the FIREFLI trial who are required to be sent a reminder letter due to non-
response to the four month questionnaire. 
 

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Statistical analysis  
Binary data will be compared using logistic regression, time to response by a Cox 
proportional hazards model, and completeness of response by a linear regression model.  All 
models will adjust for main trial allocation.