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Safe and Well Visits by the Fire and Rescue Service to Prevent Falls and Improve Quality of Life in Older People (FIREFLI)

S

Sarah Cockayne

Status

Terminated

Conditions

Quality of Life
Accidental Fall
Aged

Treatments

Other: Pen included with reminder questionaire
Other: Fire and Rescue Service Safe and Well Visit
Other: Self-Determination Theory informed trial invitation letter

Study type

Interventional

Funder types

Other

Identifiers

NCT04717258
FIREFLI Trial Protocol v6.0

Details and patient eligibility

About

FIREFLI is a large, pragmatic, individually randomised, controlled trial with embedded economic and qualitative evaluations. The aim of the research is to see whether Safe and Well Visits delivered by the Fire and Rescue Service will lead to a reduction in the number of falls and an improvement in health-related quality of life in older people. It will also look at the cost-effectiveness of the intervention and explore the acceptability of the Safe and Well Visits to older people and the Fire and Rescue Service.

The investigators will recruit 1156 participants, randomly divided into two equal groups. One group (the intervention group) will receive the Safe and Well Visit at the beginning of the study and the other group (the control group) will receive the visit at the end of the study.

The investigators will collect the number of falls people have using monthly falls calendars and follow up other outcomes by questionnaires at four, eight and 12 months post-randomisation. The investigators will also undertake interviews with some participants and with Fire and Rescue Service staff to explore experiences around the Safe and Well Visits.

Two Studies within a Trial (SWAT) will be carried out to investigate more efficient ways of running trials. The first will test if using a recruitment invitation letter informed by Self-Determination Theory will increase the number of participants who take part in the study. The second will test if including a pen with the reminder four-month questionnaire will increase the number of postal questionnaires returned to the study team.

Full description

The Fire and Rescue Services routinely carry out around 670,000 fire safety check visits in England 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 is looking at ways to prevent falls. 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. Many 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 National Health Service (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 investigators do not know is whether Safe and Well Visits undertaken by members of the Fire and Rescue Service reduce falls and can improve health-related quality of life and if they are good value for money.

To find out if Safe and Well Visits reduce the number of falls older people have and improve their quality of life, investigators will conduct a trial. The investigators will recruit 1156 people aged 70 years and over from lists of people held on Fire and Rescue Service databases or by advertising for participants and 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 United Kingdom and their usual care from their General Practitioner and other health care professionals. Participants will be asked to fill in monthly falls calendars and three postal 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 investigators may send questionnaires in the post. Researchers will analyse the data to find out if the Safe and Well Visits reduce falls and if they are good value for money. The investigators also want to find out if the Safe and Well Visits are acceptable to older people and to the Fire and Rescue Service. This will be explored through a series of in-depth interviews. The investigators will assess treatment fidelity using the following strategies: observations of those delivering the Safe and Well Visits; delivery inventory will be completed for each participant; participant outcome questionnaires will include information on adherence with the intervention; and interviews with trial participants and members of the Fire and Rescue Service who delivered the Safe and Well Visits.

In addition to the main FIREFLI study investigators will undertake two additional trial methodological Studies within a Trial (SWAT) to evaluate one recruitment and one retention strategy. The first will test if using a recruitment invitation letter informed by Self-Determination Theory will increase the number of participants who take part in the study. The second will test if including a pen with the reminder four-month questionnaire will increase the number of postal questionnaires returned to the study team.

Once the trial is completed, the investigators will make sure the results can be used by as many people as possible. They will send the people who took part in the study a summary of the findings, and the results will be presented at relevant conferences and published in scientific journals. Investigators will share these findings with other Fire and Rescue Services.

Enrollment

63 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Main FIREFLI trial

Inclusion Criteria:

  • Men and women aged 65 years and over in the Humberside FRS area or aged 79 and over in the Kent Fire and Rescue Service (FRS) area
  • 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) 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

For those participants who have been sent a recruitment pack directly from York Trials Unit (YTU) in response to advertising or hearing about the study, as opposed to receiving an invitation and recruitment pack via the mail out 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. In these circumstances, there is another exclusion criterion: Not eligible for a Safe and Well Visit with the FRS.

Recruitment Study within a trial (SWAT)

Inclusion criteria Any patient identified by the Fire and Rescue Service as eligible to receive a FIREFLI trial invitation pack.

Retention SWAT 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

63 participants in 6 patient groups

Main FIREFLI trial: Intervention arm
Experimental group
Description:
Usual care from healthcare professionals; falls prevention leaflet; Safe and Well Visits (SWVs) offered by the Fire and Rescue Service (FRS) (either a firefighter, day duty safety advocate or home safety officer) once randomised.
Treatment:
Other: Fire and Rescue Service Safe and Well Visit
Main FIREFLI trial: Control arm
No Intervention group
Description:
Usual care from healthcare professionals; falls prevention leaflet; Safe and Well Visits (SWVs) by the Fire and Rescue Service (FRS) (either a firefighter, day duty safety advocate or home safety officer offered 12 months post-randomisation)
Recruitment SWAT: Self-Determination Theory informed invitation letter
Experimental group
Description:
The recruitment pack to take part in the FIREFLI study will include an invitation letter informed by Self-Determination Theory.
Treatment:
Other: Self-Determination Theory informed trial invitation letter
Recruitment SWAT: Standard invitation letter
No Intervention group
Description:
The recruitment pack to take part in the FIREFLI study will include the University of York, York Trials Unit's standard invitation letter
Retention SWAT: Pen arm
Experimental group
Description:
A pen (which has the University of York logo on it) will be included with the first four-month reminder questionnaire.
Treatment:
Other: Pen included with reminder questionaire
Retention SWAT: No pen
No Intervention group
Description:
No pen will be included with the four-month reminder questionnaire.

Trial documents
1

Trial contacts and locations

2

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Central trial contact

Sarah Cockayne, MSc

Data sourced from clinicaltrials.gov

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