Clinical trial NCT04717258: Safe and Well Visits by the Fire and Rescue Service to Prevent Falls and Improve Quality of Life in Older People
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Accidental Fall
Quality of Life
Aged
Lead sponsor: University of York
Sponsor class: OTHER
Collaborators: name: Humberside Fire and Rescue Service
name: Leicestershire Partnership NHS Trust
name: University of Nottingham
name: Kent Fire and Rescue Service
name: James Cook University, Queensland, Australia
name: Queensland Health
First posted: 2021-01-22
Enrollment: 63
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study consists of a two-arm main trial, with two embedded two-arm SWATs.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Main FIREFLI Trial: The Number of Self-reported Falls Per Participant Over the 12 Months From Randomisation.
timeFrame: Falls per participant over the 12 months from randomisation.
measure: Health-related Quality of Life Measured by the EuroQol 5 Dimensions, 5 Level Version
timeFrame: Over the 12 months from randomisation.
measure: Recruitment SWAT: Recruitment to the FIREFLI Trial.
timeFrame: End of recruitment - approximately one year.
measure: Retention SWAT: Four-month Questionnaire Response Rate.
timeFrame: Four months from randomisation.
measure: The EuroQol-5D Visual Analogue Scale
timeFrame: Over 12 months since randomisation
Secondary outcomes:
measure: Time to First Fall and Between Subsequent Falls.
timeFrame: Over the 12 months from randomisation.
measure: Proportion of Participants Reporting at Least One Fall.
timeFrame: Over the 12 months from randomisation.
measure: Proportion of Participants Reporting Two or More Falls.
timeFrame: Over the 12 months from randomisation.
measure: Fear of Falling
timeFrame: At four, eight and 12 months post-randomisation measured by asking participants to score how often they have worried about having a fall in the past four weeks.
measure: Universtiy of California Los Angeles (UCLA) 3-item Loneliness Scale
timeFrame: At four, eight and 12 months post-randomisation.
measure: Fall Related Injuries and Costs.
timeFrame: At four, eight and 12 months post-randomisation.
measure: Fire Risk Taking Behaviours
timeFrame: At four, eight and 12 months post-randomisation.
measure: Uptake of Flu Jab
timeFrame: Over the 12 months from randomisation.
measure: Smoking/Vaping Status of Residents Within the Property
timeFrame: At four, eight and 12 months post-randomisation.
measure: Participant Reported Fire Within the Property That the FRS Attended at Four, Eight and 12 Months Post-randomisation.
timeFrame: At four, eight and 12 months post-randomisation.
measure: Participant Reported Fire Within the Property That Did Not Require the FRS to Attend.
timeFrame: At four, eight and 12 months post-randomisation.
measure: Attendances to Participants' Homes for Fire Related Incidents as Recorded by the FRS.
timeFrame: At four, eight and 12 months post-randomisation..
measure: Recruitment SWAT: Proportion of Participants Who Return a Screening Form
timeFrame: Enrollment
measure: Recruitment SWAT: Proportion of Participants Who Are Eligible for Randomisation
timeFrame: Enrollment
measure: Recruitment SWAT: Retention in the Trial at Three Months Post-randomisation
timeFrame: Three months post-randomisation.
measure: Retention SWAT: Time to Response
timeFrame: Four months post-randomisation.
measure: Retention SWAT: Completeness of Response
timeFrame: Four months post-randomisation.
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Humberside Fire and Rescue Service
state: East Yorkshire
city: Maidstone
country: United Kingdom
facility: Kent Fire and Rescue Service
state: Kent
Study officials:
affiliation: University of York
name: Sarah Cockayne
role: PRINCIPAL_INVESTIGATOR
References: