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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Accidental Fall, Quality of Life, Aged

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


Participation Criteria
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Eligibility Criteria
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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 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 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. In these circumstances, there is another exclusion criterion: Not eligible for a Safe and Well Visit with the FRS. Recruitment SWAT Inclusion criteria Any patient identified by the Fire and Rescue Service mail out 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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study consists of a two-arm main trial, with two embedded two-arm SWATs.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Main FIREFLI trial: Intervention arm<br>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. | Other: Fire and Rescue Service Safe and Well Visit<br>* Safe and Well Visits by the Fire and Rescue Service to prevent falls and improve quality of life in an older population<br>|
| No Intervention: Main FIREFLI trial: Control arm<br>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) | |
| Experimental: Recruitment SWAT: Self-Determination Theory informed invitation letter<br>The recruitment pack to take part in the FIREFLI study will include an invitation letter informed by Self-Determination Theory. | Other: Self-Determination Theory informed trial invitation letter<br>* Invitation letter to take part in the FIREFLI study informed by Self-Determination Theory<br>|
| No Intervention: Recruitment SWAT: Standard invitation letter<br>The recruitment pack to take part in the FIREFLI study will include the University of York, York Trials Unit's standard invitation letter | |
| Experimental: Retention SWAT: Pen arm<br>A pen (which has the University of York logo on it) will be included with the first four-month reminder questionnaire. | Other: Pen included with reminder questionaire<br>* A pen will be included with the four-month reminder questionnaire.<br>|
| No Intervention: Retention SWAT: No pen<br>No pen will be included with the four-month reminder questionnaire. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main FIREFLI trial: The number of self-reported falls per participant over the 12 months from randomisation. | 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 rest on the ground, floor, or lower level. Data will be collected prospectively via participant-reported monthly falls calendars. | Falls per participant over the 12 months from randomisation. | 
| Health-related quality of life measured by the EuroQol 5 Dimensions, 5 Level version | Health-related quality of life measured by the EuroQol 5 Dimensions, 5 Level version (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, respondents state whether they have no problems, slight problems, moderate problems, severe problems, or are unable to perform the activity. It also presents a visual analogue scale (VAS) graded 0 to 100 with the inserts worst conceivable health condition and best conceivable health condition in 0 and 100 respectively. | Over the 12 months from randomisation. | 
| Recruitment SWAT: Recruitment to the FIREFLI trial. | The proportion of participants randomised into the main FIREFLI trial calculated as the number of participants randomised to the main FIREFLI trial divided by the total number of recruitment packs mailed out to potential participants. | End of recruitment - approximately one year. | 
| Retention SWAT: Four-month questionnaire response rate. | The proportion of four-month reminder questionnaires returned to the York Trials Unit (YTU) calculated as the number of returned four-month follow-up questionnaires divided by the total number of four-month questionnaires mailed out to participants. | Four months from randomisation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first fall and between subsequent falls. | Time to each fall, with censoring at date of withdrawal, death or end of 12 month follow-up measured using fall data from monthly falls calendars or follow-up questionnaires. The time to the first fall will be derived as the number of days from randomisation until the patient reports having a fall. Time in days between any subsequent falls will also be calculated. | Over the 12 months from randomisation. | 
| Proportion of participants reporting at least one fall. | Proportion of participants reporting at least one fall in the 12 months from randomisation calculated as the number who report at least one fall on their monthly falls calendars or participant follow-up questionnaires divided by the total number of randomised participants. | Over the 12 months from randomisation. | 
| Proportion of participants reporting two or more falls. | Proportion of participants reporting at least two falls in the 12 months from randomisation calculated as the number who report at least one fall on their monthly falls calendars or participant follow-up questionnaires divided by the total number of randomised participants. | Over the 12 months from randomisation. | 
| Fear of falling | Participants will be asked to score how often they have worried about falling in the past four 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 of the time). This will be scored from a minimum of 1 to a maximum of 6, with a higher score indicating less concern about falling and a better outcome. | 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. | 
| Loneliness (UCLA 3-item) | The UCLA 3-item loneliness scale comprises of three questions that measure three dimensions of loneliness: 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. | At four, eight and 12 months post-randomisation. | 
| Fall related injuries and costs. | Fall-related injuries and costs over the 12 months from randomisation measured using participant self-reported data from follow-up questionnaires at four, eight and 12 months post-randomisation. The following data will be collected: injuries, healthcare resource use in primary care and community (i.e. General Practitioner, occupational therapist and physiotherapist) and secondary care (i.e. inpatient nights in hospital, day case attendances, outpatient attendances, and accident and emergency). Data on participant's time and expenses (i.e. travel costs and additional equipment) and informal care provided by friends/family, including productivity losses, will also be collected. | At four, eight and 12 months post-randomisation. | 
| Fire risk taking behaviours | Fire risk taking behaviours measured using participant self-report. | At four, eight and 12 months post-randomisation. | 
| Uptake of flu jab | Uptake of flu jab using participant self-reported flu vaccination within the past 12 months. | Over the 12 months from randomisation. | 
| Smoking/vaping status of residents within the property | Smoking/vaping status of residents within the property, smoking or vaping inside the property, smoking in bed, and referral to NHS stop smoking services at four, eight and 12 months measured using participant self-reported data from follow-up questionnaires at four, eight and 12 months. | At four, eight and 12 months post-randomisation. | 
| Participant reported fire within the property that the FRS attended. | Fire incident. | At four, eight and 12 months post-randomisation. | 
| Participant reported fire within the property that did not require the FRS to attend. | Fire incident. | At four, eight and 12 months post-randomisation. | 
| Attendances to participants' homes for fire related incidents as recorded by the FRS. | Fire incident. | Over the 12 months from randomisation. | 
| Recruitment SWAT: proportion of participants who return a screening form | Proportion of participants who return a screening form calculated as the number of participant-completed screening forms returned to YTU divided by the number of screening forms posted out to potential participants. | Enrollment | 
| Recruitment SWAT: proportion of participants who are eligible for randomisation | Proportion of participants who are eligible for randomisation calculated as the number of participants assessed as eligible for randomisation by researchers at YTU divided by the number of screening forms posted out to potential participants. | Enrollment | 
| Recruitment SWAT: retention in the trial at three months post-randomisation | Proportion of participants who remain in the trial at three months post-randomisation calculated as the number of participants who return at least the first three months' worth of falls calendars from the date of randomisation, divided by the number of screening forms posted out to potential participants. This will also be calculated as a proportion of randomised participants. | Three months post-randomisation. | 
| Retention SWAT: time to response | Time to response calculated as the number of days between the four-month questionnaire being mailed out to the participant and the questionnaire recorded as being returned to York Trials Unit measured using the date the four-month questionnaire was mailed out and received back at YTU. | Four months post-randomisation. | 
| Retention SWAT: completeness of response | The number of completed questions on the four month questionnaire. | Four months post-randomisation. |