Unit 1 Fire Safety

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RESEARCH ARTICLE

Evaluating implementation of a fire-

prevention injury prevention briefing in

children’s centres: Cluster randomised

controlled trial

Toity Deave 1 , Adrian Hawkins

2 , Arun Kumar

3 , Mike Hayes

4 , Nicola Cooper

5 ,

Michael Watson 6 , Joanne Ablewhite

3 , Carol Coupland

3 , Alex Sutton

5 , Gosia Majsak-

Newman 7 , Lisa McDaid

8 , Trudy Goodenough

1 , Kate Beckett

9 , Elaine McColl

2,10 ,

Richard Reading 11

, Denise Kendrick 3*

1 Centre for Child & Adolescent Health, Health & Applied Sciences, University of the West of England Bristol,

Bristol, United Kingdom, 2 Institute of Health & Society, Baddiley-Clark Building, Newcastle University,

Newcastle upon Tyne, United Kingdom, 3 Division of Primary Care, School of Medicine, University of

Nottingham, Nottingham, United Kingdom, 4 Child Accident Prevention Trust, Barnet, London, United

Kingdom, 5 Department of Health Sciences, University of Leicester, Leicester, United Kingdom, 6 Faculty of

Medicine and Health Sciences, School of Health Sciences, University of Nottingham, Nottingham, United

Kingdom, 7 Norfolk and Suffolk Primary and Community Care Research Office, Hosted by South Norfolk

CCG, Norwich, United Kingdom, 8 Norfolk and Norwich University Hospital, NHS Clinical Research and

Trials Unit, Norwich Medical School, University of East Anglia, Norwich, United Kingdom, 9 University of the

West of England, Research and Innovation, University Hospitals Bristol NHS Foundation Trust, Education

Centre, Bristol, United Kingdom, 10 Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon

Tyne, United Kingdom, 11 Jenny Lind Paediatric Department, Norfolk and Norwich University Hospital,

Norwich, United Kingdom

* [email protected]

Abstract

Background

Many developed countries have high mortality rates for fire-related deaths in children aged

0–14 years with steep social gradients. Evidence-based interventions to promote fire safety

practices exist, but the impact of implementing a range of these interventions in children’s

services has not been assessed. We developed an Injury Prevention Briefing (IPB), which

brought together evidence about effective fire safety interventions and good practice in

delivering interventions; plus training and facilitation to support its use and evaluated its

implementation.

Methods

We conducted a cluster randomised controlled trial, with integrated qualitative and cost-

effectiveness nested studies, across four study sites in England involving children’s centres

in disadvantaged areas; participants were staff and families attending those centres. Cen-

tres were stratified by study site and randomised within strata to one of three arms: IPB plus

facilitation (IPB+), IPB only, usual care. IPB+ centres received initial training and facilitation

at months 1, 3, and 8. Baseline data from children’s centres were collected between August

PLOS ONE | https://doi.org/10.1371/journal.pone.0172584 March 24, 2017 1 / 23

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OPEN ACCESS

Citation: Deave T, Hawkins A, Kumar A, Hayes M,

Cooper N, Watson M, et al. (2017) Evaluating

implementation of a fire-prevention injury

prevention briefing in children’s centres: Cluster

randomised controlled trial. PLoS ONE 12(3):

e0172584. https://doi.org/10.1371/journal.

pone.0172584

Editor: Belinda J Gabbe, Monash University,

AUSTRALIA

Received: January 12, 2016

Accepted: February 5, 2017

Published: March 24, 2017

Copyright: © 2017 Deave et al. This is an open access article distributed under the terms of the

Creative Commons Attribution License, which

permits unrestricted use, distribution, and

reproduction in any medium, provided the original

author and source are credited.

Data Availability Statement: Data are available

within the paper and its Supporting Information

files. Participants were not asked on the consent

form to provide consent to data sharing, so further

patient data is not publicly available. For more

information, please contact the corresponding

author at [email protected].

Funding: This paper presents independent

research funded by the National Institute for Health

Research (NIHR) under its Programme Grants for

2011 and January 2012 and follow-up data were collected between June 2012 and June

2013. Parent baseline data were collected between January 2012 and May 2012 and follow-

up data between May 2013 and September 2013. Data comprised baseline and 12 month

parent- and staff-completed questionnaires, facilitation contact data, activity logs and staff

interviews. The primary outcome was whether families had a plan for escaping from a house

fire. Treatment arms were compared using multilevel models to account for clustering by

children’s centre.

Results

1112 parents at 36 children’s centres participated. There was no significant effect of the

intervention on families’ possession of plans for escaping from a house fire (adjusted odds

ratio (AOR) IPB only vs. usual care: 0.93, 95%CI 0.58, 1.49; AOR IPB+ vs. usual care 1.41,

95%CI 0.91, 2.20). However, significantly more families in the intervention arms reported

more behaviours for escaping from house fires (AOR IPB only vs. usual care: 2.56, 95%CI

01.38, 4.76; AOR IPB+ vs. usual care 1.78, 95%CI 1.01, 3.15).

Conclusion

Our study demonstrated that children’s centres can deliver an injury prevention intervention

to families in disadvantaged communities and achieve changes in home safety behaviours.

Introduction

Childhood fire-related deaths and injuries are an important global issue[1] and are one of the

leading causes of deaths for children under 14 years in the US.[2] In 2009, almost 119,000 U.S.

children were injured severely enough due to unintentional fires and burns that they had to

visit an ED. Fires and burns are one of the major causes of nonfatal unintentional injuries in

children in the US. [2] Compared with other high-income countries, the UK has high mortal-

ity rates for deaths from fire and flames in children aged 0–14 years with steep social gradients

in mortality.[1, 3, 4]

Some interventions are effective in reducing the risk of fire-related injury and in promoting

fire-prevention practices.[5–8] Smoke alarms can reduce the risk of death in house fires.[5, 6]

Providing education and smoke alarms can increase the prevalence of working smoke alarms

and educational interventions can increase the prevalence of plans for escaping from house

fires.[7, 8] Although evidence-based interventions to promote fire safety practices exist, trans-

lating research findings into practice does not always occur. Injury prevention programmes

are unlikely to achieve their aims if they are not effectively implemented. Knowing how effec-

tive interventions can be implemented more widely is a major challenge in injury prevention.

To address this translational gap, we developed a fire prevention intervention comprising an

Injury Prevention Briefing (IPB)[9] that combined guidance on best practice for delivering

injury prevention programmes in a real-world setting with evidence of effectiveness of inter-

ventions, along with training and a facilitation package to support implementation of the IPB.

The IPB was designed for use by children’s services such as children’s centres in the UK or

Head Start programmes in the US. These services aim to improve outcomes for young children

and to reduce inequalities in health, with a particular focus on the most disadvantaged.[10–12]

They provide community-based services, information and support for families. Children’s

Community-based cluster RCT of the implementation of an injury prevention briefing

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Applied Research Programme (RP-PG-0407-

10231). The views expressed in this article are

those of the authors and not necessarily those of

the NHS, the NIHR or the Department of Health.

The institutions of the authors therefore received

funds for us to carry out the research. The funders

had no role in study design, data collection and

analysis, decision to publish, or preparation of the

manuscript.

Competing interests: The authors have declared

that no competing interests exist.

centres focus on those with pre-school children, similar to those in Head Start, a US govern-

ment-funded programme that serves low income families with children between 3-5years.[13]

The services include home safety interventions and serve populations at particular risk of fire-

related injury. However, the effectiveness of delivering a range of fire prevention activities,

such as those included in the IPB in such settings is unknown. In this paper, we report on the

evaluation of the effectiveness and cost effectiveness of implementing the IPB in children’s

centres in the UK.

Methods

Design and setting

We undertook a three-arm multi-centre cluster randomised controlled trial (RCT), with inte-

grated economic evaluation, in four sites in England (Nottingham, Bristol, Norwich and New-

castle). We used a cluster RCT to prevent contamination between families who attended the

same children’s centre and because intervention delivery was more pragmatic at children’s

centre level. Embedded qualitative interviews with key children’ staff at these sites provided

additional contextual information regarding facilitators and barriers to IPB implementation.

[14] Full details of the methods used[15] and of the qualitative analysis[14] are reported

elsewhere.

Participants

Children’s centres were invited to participate if their catchment area had more than 50% of

under-5 year-olds living in one of the 30% most disadvantaged super output areas in England,

which are geographical areas for the collection and publication of small area statistics.[16]

Recruitment took place between 03/08/2011 and 10/01/2012.

Families living in the children’s centre catchment area, who had attended the centre in the

previous three months with parents aged at least 16 years and a child under three years, were

eligible. Recruitment took place between 05/01/2012 and 31/05/2012. The recruitment strate-

gies are described elsewhere.[15, 17] For both children’s centres and families, recruitment was

defined as providing written consent and completion of baseline questionnaire. All partici-

pants completed a consent form.

Intervention

The intervention was developed using the UK Medical Research Council (MRC) guidance for

the development and evaluation of complex interventions[18] and included identifying the

evidence-base, identifying appropriate theory and modelling processes and outcomes. Evi-

dence about the effectiveness of interventions was ascertained from a systematic review of

interventions to prevent home injuries, including those from house fires[7] and a systematic

review of facilitators and barriers for home injury prevention interventions for pre-school

children.[19] Evidence about the design, content and delivery of the intervention came from

several sources, including the Health Development Agency ‘Effective Action Briefing’ for put-

ting evidence into practice for the promotion of domestic smoke alarms[20] and a review of

reviews of literature on the implementation and facilitation of health promotion interventions,

undertaken as preliminary work for this trial. We also interviewed national and local leaders,

undertook workshops, one in each trial site, with community practitioners, staff in children’s

centres, from the Fire and Rescue Service, NHS and commissioners. By doing this, we brought

together the scientific evidence on what works, with best practice from those who deliver

injury prevention programmes in the community.

Community-based cluster RCT of the implementation of an injury prevention briefing

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A number of common themes emerged from the review of reviews; four reviews had con-

vergent findings about the explanatory factors that affect the implementation of community

prevention programmes; one of which was training and technical assistance.[21–24] However

national guidance documents, such as those from the National Institute for Care Excellence,

are often provided in the UK without such support. The trial therefore comprised two inter-

vention arms, one where the IPB was provided with training and facilitation (described below)

the other provided the IPB without training and facilitation.

The intervention was developed based on five behavioural change theories (health belief

model, social cognitive theory, theory of reasoned action, theory of self-regulation and self-

control and theory of subjective culture and interpersonal relations) from a review of behav-

iour change theories for injury prevention.[25] Our intervention aimed to address the three

factors described as necessary and sufficient for producing a behaviour change by helping par-

ticipants (both children’s centre staff and families) form intentions to change behaviour,

remove environmental barriers and provide participants with the knowledge and skills to per-

form the behaviour.

There were two intervention arms and one usual care arm:

1. IPB delivery, a three hour staff training session and on-going facilitation to support imple-

mentation (IPB+);

2. IPB posted to children’s centre (IPB only);

3. Children’s centre undertake usual fire prevention activity (usual care).

The IPB was developed specifically for use in children’s centres[9] using a seven-step pro-

cess.[20, 26] The IPB provided advice, information and activities to support delivery of five

key fire safety messages: smoke alarm use and maintenance, plans for escaping from a house

fire, potential causes of house fires, safe storage of matches and lighters and bedtime fire safety

routines. The training provided information on fire-related injuries; development, principles

and content of the IPB; practice in using the IPB and in the development of the IPB implemen-

tation plan.

The facilitation comprised telephone or face-to-face contacts from the research team at 1, 3

and 8 months to collect information on implementation progress, address questions and

barriers to implementation and provide advice, examples of good practice, a resource list and

contacts with other organisations, e.g., fire and rescue service. Children’s centres vary consid-

erably in their management and operational processes and in the populations they serve but

they are experienced in delivering health promotion programmes. For this reason, and to

ensure the implementation of the IPB reflected the real-world setting, they were asked to

develop a plan for implementing the IPB which was most suitable to their circumstances and

those of the families they serve. If they were unable to deliver all five fire-safety messages, they

were asked to focus on smoke alarms and fire escape plans as these have the strongest evi-

dence-base. Children’s centres used their usual centre processes for disseminating information

about the IPB to staff, both current and new.

Outcomes

The primary outcome was a family level binary variable for whether or not the family had a

plan for escaping from a house fire. Secondary outcomes are described in Box 1:

Outcomes were ascertained 12 months post-intervention commencement in the IPB+ and

IPB only arms and 12 months post-randomisation in the usual care arm, plus facilitation

Community-based cluster RCT of the implementation of an injury prevention briefing

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contact data which were collected at 1,3 and 8 months post commencement of the intervention

in the IPB+ arm.

Outcomes were measured using a range of tools. Families completed baseline and 12

month follow-up questionnaires. Data from children’s centres included baseline and post-

intervention manager-completed questionnaires, facilitation questionnaires and interviews

with the IPB+ children’s centre staff at 1, 3 and 8 months and activity logs to record home

safety activities. The two intervention arms also completed questionnaires and interviews to

assess implementation fidelity at 12 months.[14] Baseline data from children’s centres were

Box 1. Secondary outcomes

Family outcomes

1. Intervention family reported more fire escape behaviours than those families in the

control group (using a binary measure derived from five component items using

latent variable analysis. The component items are: having door keys accessible, hav-

ing window lock keys accessible, having a torch beside the bed, knowing the sound

of a smoke alarm and having exits clear);

2. Family had smoke alarms fitted and working on every level of their home;

3. Family reported fire-setting or match play by their children;

4. Family reported bedtime fire safety routine score;

5. Family had accessed smoking cessation services;

6. The number of correct responses to fire safety knowledge questions;

7. Family reported being fairly satisfied or very satisfied with home safety information

provided by children’s centres;

8. Implementation of the IPB assessed by:

a. Family had received advice on each of the 5 key messages in the IPB in the last

year;

b. Family had attended a fire safety session in the last year;

c. The number of fire safety sessions attended by family in the last year;

d. Family had attended a fire safety session at a children’s centre in the last year;

e. Family had attended sessions about each of the 5 key messages in the IPB in the

last year;

9. Family’s resource-use and expenditure in relation to fire safety practices.

Children’s centre outcomes

10. Children’s centre provided information and advice on fire prevention;

11. Resource use and expenditure incurred in relation to fire prevention activities

12. Reported implementation of the IPB within children’s centres;

13. Barriers and facilitators to children’s centres implementing the IPB.

Community-based cluster RCT of the implementation of an injury prevention briefing

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collected between August 2011 and January 2012 and follow-up data, including facilitation

contact data were collected between June 2012 and June 2013. Parent baseline data were col-

lected between January 2012 and May 2012 and follow-up data between May 2013 and Sep-

tember 2013. Follow-up data were analysed in 2014.

Randomisation

Children’s centres were stratified by study site (4 strata) and randomly allocated within strata

to one of the three study arms using permuted block randomisation, with fixed block sizes of

3; thus, in each of the four study sites, three children’s centres were allocated to each arm. The

allocation schedule was produced by an independent statistician, using the Stata randomisa-

tion algorithm. Allocations were placed in sequentially numbered opaque envelopes (one set

for each trial site). When a study site (stratum) had recruited its first three children’s centres,

and each of those centres had recruited 30 families, the first three envelopes were opened by an

administrator not otherwise involved in the trial and the allocation of those centres to study

arm was revealed. The same process was followed after the recruitment of children’s centres

4–6 and 5–9 at each study site.

Blinding

It was not possible to blind children’s centre staff, or researchers providing the intervention to

treatment arm allocation, but parents were blinded to treatment arm allocation. Analyses were

undertaken blind to treatment arm allocation.

Sample size

The sample size was calculated for the primary outcome (a binary variable for whether or not

the family had a plan for escaping from a house fire). The number of families and clusters

required were obtained by calculating the sample size required for an individually randomised

trial then applying the design effect derived from the intraclass correlation coefficient and the

cluster size to account for clustering of families within children’s centres using published for-

mulae for cluster randomised trials.[27] Eleven children’s centres per intervention arm (a total

of 33 centres across the four study sites) were required to detect an absolute difference in the

percentage of families with a plan for escaping from a house fire of 20% (equivalent to an odds

ratio of 2.25) in either of the two intervention arms compared with the control arm. This

assumed a prevalence of 42% for families in the control arm having a plan for escaping from a

house fire, an intraclass correlation coefficient of 0.05,[28] outcomes being available on 20

families per children’s centre (giving a design effect of 1.95), 80% power and 5% significance

level (2-sided). To allow for attrition, we increased the number of children’s centres to 36 and

the average number of families recruited per centre to 30, giving a total of 1080 families across

the four study sites (9 children’s centres and 270 families per study site).

Statistical analysis

Baseline characteristics were summarised by treatment arm. Quantitative analyses were under-

taken using a pre-specified analysis plan on an intention-to-treat basis using Stata versions 11

and 13.

Primary outcome. The primary outcome (a binary outcome of whether the family had a

plan for escaping from a house fire) was analysed using random effects logistic regression to

estimate odds ratios and 95% CIs, comparing families in the two intervention arms with the

control arm, with children’s centre included as a random effect. The model included

Community-based cluster RCT of the implementation of an injury prevention briefing

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randomisation stratum (trial site) as a fixed effect and was adjusted for two children’s centre-

level variables (lead agency (Local Authority, National Health Service or Voluntary sector) and

Ofsted scores for overall effectiveness (Ofsted inspects and regulates services that care for chil-

dren and young people and services providing education and skills for learners of all ages) and

two family-level variables (plan for escaping from a house fire at baseline and Index of Multiple

Deprivation (IMD) 2010 score based on home postcode).[16] The IMD is a small (400–1200

households) area-based measure of deprivation comprising seven domains (income, employ-

ment, health and disability, education skills and training, barriers to housing and services, liv-

ing environment and crime).

As a secondary analysis, we tested for differential effects of interventions by deprivation by

adding interaction terms to the model. We used one way analysis of variance to calculate the

intraclass correlation coefficient.

Secondary outcomes. For secondary outcomes measured at family-level, we analysed

binary outcomes using random effects logistic regression, the number of correct responses to

fire safety knowledge questions using random effects ordinal regression and the bedtime safety

routine score using random effects linear regression. Models were adjusted for the same base-

line covariates included in the model for the primary outcome, as described above. Statistical

analysis of secondary outcomes measured at children’s centre-level was not undertaken due to

small numbers in some groups.

Sensitivity analyses. The main analyses for all outcomes were complete case analyses. For

the primary outcome we undertook sensitivity analyses, (a) using multiple imputation to

replace missing values and created 50 datasets which were combined using Rubin’s rules,[29]

and, (b) assuming no change from baseline values in those lost to follow-up.

Health economic evaluation

The cost-effectiveness analysis was conducted from a societal perspective and used the primary

effectiveness endpoint of the trial and economic endpoint of the total cost of the intervention

(expressed in 2012 UK£), with data analysed at family-level. Resource use and cost data were

obtained from: i) activity logs (relating to implementation of intervention); ii) children’s centre

follow-up questionnaires (detailing fire safety activities); iii) parent follow-up questionnaires

(resources and costs related to fire safety sessions and home safety inspections). Study site and

children’s centre-level costs were averaged equally across families within each study site and

children’s centre, respectively, and combined with family-level costs to give a total cost per

family. The primary outcome was cost per additional plan for escaping from a house fire esti-

mated for the IPB only and IPB+ arms compared to the usual care arm.

We adopted a hierarchical modelling approach, allowing for clustering and adjusting for

the baseline covariates included in the primary effectiveness analysis. This model extended

recently developed methodology [30, 31] for cost-effectiveness analysis alongside cluster trials

(see S1 Text for further details). This approach used Markov Chain Monte Carlo simulation to

fit the non-standard statistical model using the WinBUGS software.[32] A summary of the

base-case cost-effectiveness analysis is provided in Table 1.

One of the children’s centres in the usual care group had extremely high costs and its

impact on the results was assessed by excluding it in a sensitivity analysis. We checked robust-

ness of findings to missing data by extending the imputation model described above for the

primary outcome to include costs incurred by (a) parents, (b) fire and rescue services, (c) chil-

dren’s centres and (d) other agencies. Since analysis was carried out using MCMC simulation

it was not practical to perform 50 imputations (as done for effectiveness), instead 10 imputa-

tions were used.

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Qualitative analysis

Data from facilitation contacts were analysed using thematic analysis after categorisation into

main sub-headings.[33] An analytical framework was developed and applied to implementa-

tion fidelity interviews using Framework Analysis,[34] supported by QSR NVivo 10.

Changes to the protocol

There were six amendments made to the protocol following approval by the ethics committee.

These were:

1. Specifying the trial was a cluster randomised controlled trial by adding the word “cluster”

to the trial title in the protocol

2. Extending recruitment of children’s centres to those with more than 50% of their catchment

population in the most 30% most deprived areas to ensure recruitment of sufficient chil-

dren’s centres

3. Increasing the number of children’s centre managers interviewed in the intervention arms

(from a sample of 18 to managers from all 24 centres) to ensure data on facilitators and bar-

riers to implementation of the IPB were collected from all centres

4. Reducing data collection contacts between research team and the IPB only arm to a single

contact at 12 months to reduce the likelihood that data collection contacts would act as

prompts to action to implement guidance that would not usually occur when guidance doc-

uments are disseminated

5. The independent Trial Steering Committee (TSC) recommended modifying the data collec-

tion at facilitation contacts in the ‘IPB plus facilitation’ arm so that a two-stage approach

was used, with a questionnaire sent prior to the interview to allow time for the data to be

collected, rather than the questionnaire being completed at the interview.

6. The independent TSC advised using latent variable analysis on the baseline data to create a

composite secondary outcome measure which measured a range of fire escape behaviours

and to include this as an additional secondary outcome measure for the trial.[35] This was

Table 1. Summary of the base-case cost-effectiveness analysis.

Type of evaluation Prospective cost-utility analysis alongside a cluster RCT

Time horizon 1-year

Perspective Societal

Comparators Usual care

Injury prevention briefing

Injury prevention briefing with facilitation

Cost categories Children’s centre

Fire and Rescue Service

Other agencies including council

Family

Base year for calculating

costs/prices

2012 UK£

Analytic methods Hierarchical model allowing for clustering and adjusting for the baseline

covariates included in the primary effectiveness analysis

Outcome Cost per additional fire escape plan

https://doi.org/10.1371/journal.pone.0172584.t001

Community-based cluster RCT of the implementation of an injury prevention briefing

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approved by the ethics committee on 7/2/13. This was prior to completion of follow up data

collection and prior to any analysis of follow up data.

Ethical and organisational review

Derbyshire Research Ethics Committee (11/EM/0011) and the University of the West of

England, Bristol, Research Ethics Committee (HSC/11/06/61) provided ethical approval on

18 th

March 2011 and 22 nd

July 2011, respectively. Primary Care Trusts (PCTs) provided NHS

organisational approval. Informed written consent was obtained from all participants

involved.

Results

Recruitment and retention

Fig 1 shows the flow of children’s centres and families through the trial. Ninety-six children’s

centres were approached, seven of which were excluded. Fifty-seven centres expressed interest

in taking part, 18 of which were excluded. Thirty-nine centres were recruited, six of which

Fig 1. Flow of children’s centres and families through the trial.

https://doi.org/10.1371/journal.pone.0172584.g001

Community-based cluster RCT of the implementation of an injury prevention briefing

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were jointly operating as three children’s centres, giving a total of 36 centres. A total of 1265

families were approached, of whom 1112 were recruited. All children’s centres remained in the

trial and 361 families (32%) were lost to follow-up. Loss to follow-up was similar across trial

arms.

Baseline characteristics

Table 2 shows the characteristics of children’s centres and families at baseline. Trial arms

appear to be well balanced. Two fifths of families (42%) had an existing plan for escaping from

a house fire with a similar proportion in each arm.

Primary and secondary outcomes

There was no significant difference in the proportion of families with a plan for escaping from

a house fire at 12 months between treatment arms (AOR IPB only vs. usual care: 0.93, 95%CI

0.58, 1.49; AOR IPB+ facilitation vs. usual care 1.41, 95%CI 0.91, 2.20) (Table 3; results for full

model in S1 Table). There was no significant interaction between deprivation and the effect of

the interventions (p = 0.86). The intraclass correlation coefficient for having a plan for escap-

ing from a house fire at 12 months was 0.003 (95% CI 0.000, 0.027) (S2 Table).

Significantly more IPB only (AOR 2.56, 95%CI 1.38, 4.76) and IPB+ arm families (AOR

1.78, 95%CI 1.01–3.15) were in the “more behaviours for escaping from house fires” group

than usual care arm families. Families in the IPB only arm were significantly less likely to

report children playing with matches or lighters (AOR 0.27, 95%CI 0.08, 0.94) and reported

significantly more bedtime fire safety routines than usual care arm families (AOR for a one

unit increase in number of bedtime fire safety routines AOR 1.59, 95%CI 1.09, 2.31).

Table 4 shows a significantly higher proportion of IPB+ arm families reported receiving

advice about each of the five key IPB messages and attended fire safety sessions on each of the

five key IPB messages than control arm families. A significantly higher proportion of IPB only

arm families attended fire safety sessions on three of the five key IPB messages than control

arm families. A significantly higher proportion of families in both intervention arms reported

attending a fire safety session than control arm families. Only a small proportion of families

attended two or more fire safety sessions (usual care: 3.9%, IPB only: 11.9%, IPB+ 19.3%).

There were no significant differences in other secondary outcome measures. Table 5 shows the

fire safety activities reported by children’s centres. Numbers were too small for statistical anal-

ysis but the findings are consistent with family-reported fire safety activities.

Sensitivity analyses

AORs from the multiple imputation analysis for the primary outcome were similar to those

from the complete case analysis (IPB only: AOR 0.92, 95%CI 0.58, 1.46; IPB+: AOR 1.40, 95%

CI 0.89, 2.21) and from the analysis assuming no change from baseline (IPB only: AOR 0.95,

95%CI 0.60, 1.51; IPB+: AOR 1.39, 95%CI 0.91, 2.12).

Health economics

Details about derivation of costings are presented in Tables 6–9. The cost of developing the

IPB (£15,860) was excluded from the cost-effectiveness analysis as this fixed, one-off cost

would not be encountered again if this intervention was implemented in practice.

Table 10 presents the results of the cost-effectiveness analysis comparing IPB only and IPB+

to usual care arms. The complete-case analysis shows the IPB only is both less costly and more

effective than usual care, whereas the IPB+ is more costly and more effective than usual care.

Community-based cluster RCT of the implementation of an injury prevention briefing

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Table 2. Baseline characteristics of children’s centres and families.

Trial Arm

Characteristics Usual care n = 12 IPB only n = 12 IPB + facilitation n = 12

Children’s centres

Study centre:

Nottingham 3 3 3

Newcastle 3 3 3

Norwich 3 3 3

Bristol 3 3 3

Lead agency:

Local Authority 10 7 9

NHS 0 0 2

Voluntary sector 2 5 1

Phase 1 centre 10 11 11

Phase 2 centre 2 1 1

Number of children in catchment area: median (IQR) 754 (529, 999) 776 (565, 905) 854 (608, 1076)

Ofsted score for overall effectiveness: [1]

Outstanding 3 2 4

Good/satisfactory 9 10 7

Children’s centre provides advice on:

Smoke alarm use 12 10 12

How to make a plan for escaping from a house fire 9 [1] 9 9

Causes of house fires 12 11 12

Safe use and storage of cigarettes, lighters & matches 10 10 [1] 9

Bedtime routines to prevent fires 6 [1] 7 9

Families Usual care n = 370 (%) IPB only n = 369 (%) IPB + facilitation n = 373 (%)

Study centre:

Nottingham 89 (24.1) 98 (26.6) 91 (24.4)

Newcastle 86 (23.2) 88 (23.9) 87 (23.3)

Norwich 95 (25.7) 82 (22.2) 93 (24.9)

Bristol 100 (27.0) 101 (27.4) 102 (27.4)

Single adult household [13] 61 (17.1) [15] 72 (20.3) [15] 59 (16.5)

Only 1 child in household [12] 169 (47.2) [13] 173 (48.6) [16] 200 (56.0)

>1 family living in same household 29 (8.0) 37 (10.0) 37 (10.0) Number of families with children aged: [10] [6] [9]

under 1 year 163 (45.3) 143 (39.4) 178 (48.9)

1–2 years 197 (54.7) 220 (60.6) 186 (51.1)

Mother aged �20 years [16] 17 (4.8) [19] 17 (4.9) [17] 20 (5.6)

Father aged �20 years [57] 6 (1.9) [67] 6 (2.0) [59] 8 (2.6)

Family ethnicity: White British [20] 337 (96.3) [18] 323 (92.0) [12] 348 (96.4)

English as first language [5] 336 (92.1) [5] 319 (87.6) [2] 349 (93.1)

Rented accommodation [13] 193 (54.1) [6] 203 (55.9) [6] 193 (52.6)

Deprivation mean (SD) (IMD of household) [2] 31.0 (16.9) [1] 34.7 (16.5) [1] 29.6 (16.1)

No smokers in household [11] 245 (68.3) [9] 251 (69.7) [10] 263 (72.5)

At least one person in household drinks �4 times/week [10] 21 (5.8) [8] 19 (5.3) [12] 24 (6.7)

At least one person in household drinks �6 drinks on one occasion [33] 208 (61.7) [38] 173 (52.3) [29] 211 (61.3)

Family have a plan for escaping from a house fire [7] 159 (43.8) [5] 153 (42.0) [7] 149 (40.7)

[] = missing values

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Table 3. Primary and secondary outcomes at 12 month follow-up by treatment arm.

Outcome measures Trial Arm IPB only vs. usual care IPB+ vs. usual care

Usual care

n = 258 (%)

IPB only

n = 252 (%)

IPB+ n = 241

(%)

Odds ratio

(95% CI)

p

value

Odds ratio

(95% CI)

p

value

Primary outcome measure 1

Family have a plan for escaping from a house

fire:

[4] [9] [5]

No 135 (53.2) 135 (55.6) 116 (49.2) 1.00 1.00

Yes 119 (46.9) 108 (44.4) 120 (50.9) 0.93 (0.58,

1.49)

0.76 1.41 (0.91,

2.20)

0.13

Secondary outcome measures 2

Fire escape behaviours composite variable:

Fewer fire escape behaviours 45 (17.4) 29 (11.5) 32 (13.3) 1.00 1.00

More fire escape behaviours 213 (82.3) 223 (88.5) 209 (86.7) 2.56 (1.38,

4.76)

<0.01 1.78 (1.01, 3.15)

0.05

Smoke alarms fitted and working on every level: [7] [12] [8]

No 22 (8.8) 14 (5.8) 13 (5.6) 1.00 1.00

Yes 229 (91.2) 226 (94.2) 220 (94.4) 1.61 (0.71,

3.66)

0.25 1.56 (0.71,

3.42)

0.27

Fire setting or match play by children: [52] [49] [49]

No 197 (95.6) 198 (97.5) 181 (84.3) 1.00 1.00

Yes 9 (3.5) 5 (2.5) 11 (5.7) 0.27 (0.08,

0.94)

0.04 1.22 (0.43,

3.08)

0.77

Bedtime fire safety routine score (median

(IQR)): 3

[9] 8 (8, 9) [16] 9 (8, 10) [11] 8.5 (8, 9) 1.59 (1.09,

2.31)

0.02 1.22 (0.85,

1.76)

0.28

Took part in smoking cessation courses/support: [60] [43] [43]

No 5 (19.2) 8 (33.3) 5 (23.8) 1.00 1.00

Yes 21 (80.8) 16 (66.7) 16 (76.2) 0.23 (0.04,

1.43)

0.12 0.61 (0.11,

3.40)

0.57

Number of correct responses to fire safety

knowledge questions: 3

0 78 (30.2) 81 (32.1) 70 (29.1) 1.10 (0.77,

1.57)

0.61 1.22 (0.86,

1.73)

0.26

1 93 (36.1) 86 (34.1) 76 (31.5)

2 80 (31.0) 81 (32.1) 85 (35.3)

3 7 (2.7) 4 (1.6) 10 (4.2)

Satisfaction with home safety information

provided by children’s centre: 4

[57] [55] [53]

Neither satisfied nor dissatisfied/fairly/very

dissatisfied

16 (8.0) 22 (11.2) 23 (12.2) 1.00 1.00

Very/fairly satisfied 31 (15.4) 46 (23.4) 73 (38.8) 1.08 (0.4, 2.8) 0.87 1.79 (0.7, 4.4) 0.20

No information received 154 (76.6) 129 (65.5) 92 (48.9)

[] = missing values 1

Adjusted for study centre, lead agency of children’s centre (Local authority, NHS or Voluntary sector), OFSTED effectiveness score (Outstanding, Good,

Satisfactory, Missing), fire escape plan at baseline (no/yes), IMD score of family (continuous). We have not adjusted for OFSTED capacity for sustained

improvement as this variable had more missing data and where recorded the values are the same as for OFSTED overall effectiveness score. 2

Adjusted for the lead agency of the children’s centre, Ofsted report scores for overall effectiveness, baseline value of the secondary outcome measure,

IMD. We have not adjusted for OFSTED capacity for sustained improvement as this variable had more missing data and where recorded the values are the

same as for OFSTED overall effectiveness score. 3

Odds ratio for a one unit increase in the outcome measure. 4

Participants who had not received information were excluded from the analysis

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Table 4. Receipt of fire safety advice and other fire safety promotion by families at follow-up, by treatment arm.

Receipt of fire safety advice and promotion Trial Arm IPB only vs. usual

care

IPB+ vs. usual care

Usual care

n = 258 (%)

IPB only

n = 252 (%)

IPB+ n = 241

(%)

Odds ratio

(95% CI) 1

p

value

Odds ratio

(95% CI) 1

p value

Received advice on the five key IPB messages:

i. Smoke alarms 2

[54] [52] [54]

No 155 (75.6) 132 (66.0) 107 (57.2) 1.00 1.00

Yes 49 (24.0) 68 (34.0) 80 (42.8) 1.36 (0.82,

2.26)

0.23 2.27 (1.40,

3.67)

p<0.01

ii. Matches 2

[56] [57] [58]

No 177 (87.6) 167 (85.6) 133 (72.7) 1.00 1.00

Yes 25 (12.4) 28 (14.4) 50 (27.3) 1.05 (0.54,

2.04)

0.89 2.74 (1.51,

4.96)

p<0.01

iii. Fire escape plans [55] [58] [57]

No 175 (86.2) 168 (86.6) 133 (72.3) 1.00 1.00

Yes 28 (13.8) 26 (13.4) 51 (27.7) 0.79 (0.40,

1.55)

0.50 2.38 (1.35,

4.21)

p<0.01

iv. Bedtime safety routines [54] [56] [56]

No 183 (89.7) 173 (88.3) 147 (79.5) 1.00 1.00

Yes 21 (10.3) 23 (11.7) 38 (20.5) 0.89 (0.44,

1.82)

0.76 2.21 (1.18,

4.12)

p<0.01

v. Causes of fires [57] [56] [57]

No 169 (84.1) 149 (76.0) 113 (61.4) 1.00 1.00

Yes 32 (15.9) 47 (24.0) 71 (38.6) 1.50 (0.85,

2.65)

0.17 3.35 (1.98,

5.68)

p<0.01

Number of key safety messages had advice on: [53] [52] [52]

2 or less 180 (87.8) 170 (85.0) 132 (69.8) 1.00 1.00

3–5 25 (12.2) 30 (15.0) 57 (30.2) 1.09 (0.57,

2.10)

0.80 3.06 (1.72,

5.43)

p<0.01

Attended a fire safety session in the last year: [53] [50] [49]

No 197 (96.1) 178 (88.1) 155 (80.7) 1.00 1.00

Attended 1 or more 8 (3.9) 24 (11.9) 37 (19.3) 3.20 (1.27,

8.06)

0.01 7.07 (3.05,

16.38)

p<0.01

Attended a fire safety session at children’s centre: [53] [50] [49]

No 197 (96.1) 185 (91.6) 163 (84.9) 1.00 1.00

Attended 1 or more 8 (3.9) 17 (8.4) 29 (15.1) 2.18 (0.85,

5.63)

0.11 5.14 (2.20,

12.03)

p<0.01

Attended fire safety session about each of the five

key messages in the IPB in the last year:* [53] [50] [49]

i. Smoke alarms

No 198 (96.6) 180 (89.1) 158 (82.3) 1.00 1.00

Yes 7 (3.4) 22 (10.9) 34 (17.7) 3.34 (1.30,

8.58)

0.01 6.71 (2.80,

16.04)

p<0.01

ii. Matches

No 201 (98.1) 189 (93.6) 169 (88.0) 1.00 1.00

Yes 4 (2.0) 13 (6.4) 23 (12.0) 2.80 (0.85,

9.29)

0.09 6.78 (2.24,

20.55)

p<0.01

iii. Fire escape plans

No 201 (98.1) 188 (93.1) 162 (84.4) 1.00 1.00

Yes 4 (2.0) 13 (6.9) 30 (15.6) 3.48 (1.06,

11.44)

0.04 9.88 (3.31,

29.43)

p<0.01

iv. Bedtime safety routines

(Continued )

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Table 4. (Continued )

Receipt of fire safety advice and promotion Trial Arm IPB only vs. usual

care

IPB+ vs. usual care

Usual care

n = 258 (%)

IPB only

n = 252 (%)

IPB+ n = 241

(%)

Odds ratio

(95% CI) 1

p

value

Odds ratio

(95% CI) 1

p value

No 202 (98.5) 189 (93.6) 172 (89.6) 1.00 1.00

Yes 3 (1.5) 13 (6.4) 20 (10.4) 3.93 (1.04,

14.93)

0.04 7.83 (2.23,

27.55)

p<0.01

v. Causes of fires

No 198 (96.6) 184 (91.1) 162 (84.4) 1.00 1.00

Yes 7 (3.1) 18 (8.9) 30 (15.6) 0.56 (0.0,

11.9)

0.06 5.52 (2.29,

13.30)

p<0.01

[] = missing

* Some families attended more than 1 session. 1

Adjusted for study centre, lead agency of children’s centre (Local authority, NHS or Voluntary sector), OFSTED effectiveness score (Outstanding, Good,

Satisfactory, Missing), baseline value of the secondary outcome measure, IMD score of family (continuous). We have not adjusted for OFSTED capacity for

sustained improvement as this variable had more missing data and where recorded the values are the same as for OFSTED overall effectiveness score. 2

IMD quintiles used because of non-linear association with the outcome.

https://doi.org/10.1371/journal.pone.0172584.t004

Table 5. Fire safety activities reported by children’s centres at follow-up, by treatment arm.

Secondary outcome measures Trial arm

Usual care IPB only IPB+ facilitation

n = 12 n = 12 n = 12

Advice provided on:

Smoke alarms [1]

No advice / Don’t know 1 0 1

Yes 11 11 11

How to make a fire escape plan [1]

No advice / Don’t know 3 3 0

Yes 8 9 12

Causes of house fires (cooking safety, electrical safety, handling hot irons safely)

No advice / Don’t know 1 0 0

Yes 11 12 12

Child behaviour and fire prevention (safe use and storage of cigarettes, lighters and matches)

No advice / Don’t know 4 11 0

Yes 8 1 12

Bedtime routines to prevent fires [1] [1]

No advice / Don’t know 6 4 0

Yes 5 8 11

Children’s centre provided fire safety sessions [1]

No 6 5 1

Yes- 5 7 11

Mean number of sessions (min to max)* 1.2 (1 to 2) 2.1 (1 to 4) 3.1 (1 to 7)

Mean session length in minutes (min to max) 116 (90 to 120) 90 (30 to 120) 89 (30 to 130)

FRS attended to help provide any sessions [1] [1]

No 8 6 4

yes 3 6 7

[] missing values.

*assumes those who said they ran a session but didn’t answer question on number of sessions, ran only one session. FRS = fire and rescue service

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As the inverse of the difference in probabilities of having a plan for escaping from a house fire

between two treatment arms is equal to the Number Needed to Treat (NNT), the cost-effective-

ness ratios can be interpreted as the cost per additional plan for escaping from a house fire

under the intervention. The cost-effectiveness acceptability curves (Fig 2) show the IPB only

has the highest probability of being cost-effective at a decision maker’s willingness to pay

between £0 and £4,000 (US$ 6061) per additional plan for escaping from a house fire.

A sensitivity analysis, excluding the children’s centre with the potentially outlying cost,

resulted in slight changes as reported in Table 10 and Fig 2. Analysis of imputed data, at values

of a decision maker’s willingness to pay above £400 (US$ 606) per additional plan for escaping

from a house fire, showed the IPB+ had the highest probability of being cost-effective

(Table 10) reaching a probability of nearly 1 at £1000 (US$ 1515) per additional fire-escape

plan. However, results should be interpreted with caution due to the large proportion of

Table 6. Sources of unit cost data (UK£ 2012).

Value Source

Parent costs

Time costs £45.70/hour Department for Transport. TAG UNIT 3.5.6 Values of Time and Vehicle Operating Costs Transport Analysis

Guidance (TAG). Available from www.dft.gov.uk/webtag [Accessed October 2012].

Travel costs by car £0.18/km Department for Transport. TAG UNIT 3.5.6 Values of Time and Vehicle Operating Costs Transport Analysis

Guidance (TAG). Available from www.dft.gov.uk/webtag [Accessed October 2012].

IPB implementation costs

Researcher’s time £19.04/hour University of Nottingham pay scale

Administrator’s time £11.24/hour University of Nottingham pay scale

Children’s centre, Fire and Rescue Service and other agency costs

FRS staff time £36.00/hour Personal communication, Adam Shaw, Cheshire Fire and Rescue Service, 20 September 2012,

Children’s centre staff’s

time

£18.00/hour Personal Social Services Research Unit. Unit costs of health and social care 2012, 2012. (assumed same as

home care worker)

Home inspection £15.33 Based on 40 minute visit by children’s centre, FRS or other agency (as in decision models)

FRS = fire and rescue service

https://doi.org/10.1371/journal.pone.0172584.t006

Table 7. Costs of providing the IPB, training and facilitation (UK £2012).

Arm Study

centre

Number of

families

randomised

Number of

children’s

centres

IPB printing &

distribution

IPB training

session

IPB

facilitation

Total per

study centre

Total per

children’s

centre

Total per family

randomised

Usual

care

Bristol 100 3 £0.00 £0.00 £0.00 £0.00 £0.00 £0.00

Newcastle 86 3 £0.00 £0.00 £0.00 £0.00 £0.00 £0.00

Norwich 95 3 £0.00 £0.00 £0.00 £0.00 £0.00 £0.00

Nottingham 89 3 £0.00 £0.00 £0.00 £0.00 £0.00 £0.00

IPB

only

Bristol 101 3 £152.50 £0.00 £0.00 £152.50 £50.83 £1.51

Newcastle 88 3 £152.50 £0.00 £0.00 £152.50 £50.83 £1.73

Norwich 82 3 £152.50 £0.00 £0.00 £152.50 £50.83 £1.86

Nottingham 98 3 £152.50 £0.00 £0.00 £152.50 £50.83 £1.56

IPB + Bristol 102 3 £152.50 £1,328.95 £327.84 £1,809.29 £603.10 £17.74

Newcastle 87 3 £152.50 £1,408.84 £220.57 £1,781.91 £593.97 £20.48

Norwich 93 3 £152.50 £1,488.74 £127.90 £1,769.14 £589.71 £19.02

Nottingham 91 3 £152.50 £1,568.63 £84.74 £1,805.87 £601.96 £19.84

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missing data imputed (ranging from just under 50% (families’ costs) to nearly 60% (children’s

centre costs)).

Qualitative analysis

The qualitative data have been reported previously.[14] However, the results provided clear

indications of factors, e.g. organisational change, time and resources which moderated all chil-

dren’s centres’ ability to implement the IPB. More specific factors which adversely affected

implementation of the IPB by some children’s centres were also identified, e.g. staff training

and continuity.

Discussion

Main findings

This three-arm cluster randomised controlled trial examined the effects of a complex interven-

tion on fire safety behaviours in the home. We found that families in both intervention arms

reported significantly more behaviours for escaping from house fires. Families in both

Table 9. Total intervention costs expressed per cluster (i.e. children’s centre) and per family.

Usual care - Mean (Min to Max) IPB only - Mean (Min to Mix) IPB + facilitation - Mean (Min to

Max)

per cluster per family per cluster per family per cluster per family

9 clusters 151 families 9 clusters 140 families 9 clusters 123 families

IPB provision, training and facilitation

plus other intervention costs

£303.01 (30.66 to

1367.67)

£18.06 (0.00 to

90.43)

£143.68 (62.51 to

240.22)

£9.24 (1.51 to

46.79)

£507.81 (290.26

to 859.92)

£37.16 (21.18 to

79.20)

Other intervention costs only £303.01 (30.66 to

1367.67)

£18.06 (0 to

90.43)

£117.87 (45.89 to

210.58)

£7.58 (0.00 to

45.06)

£224.97 (110.66

to 497.62)

£16.46 (2.70 to

51.33)

https://doi.org/10.1371/journal.pone.0172584.t009

Table 8. Other intervention costs expressed per cluster (i.e. children’s centre) and per family.

Usual care - Mean (Min to Max) IPB only - Mean (Min to Mix) IPB + facilitation - Mean (Min to Max)

per cluster per family per cluster per family per cluster per family

9 clusters 151 families 9 clusters 140 families 9 clusters 123 families

Fire safety sessions

Children’s centre costs £421.00 (0.00 to

1800*) £13.72 (0.00 to

62.07)

£63.00 (0.00 to

198.00)

£2.06 (0.00 to

7.07)

£222.00 (0.00 to

900.00)

£7.63 (0.00 to

32.14)

Fire & Rescue service

costs

£74.38 (0.00 to

378.00)

£2.57 (0.00 to

13.03)

£68.66 (0.00 to

288.00)

£2.20 (0.00 to

9.60)

£136.49 (0.00 to

372.00)

£4.38 (0.00 to

11.63)

Parent costs to attend

sessions

£2.59 (0.00 to

22.85)

£0.15 (0.00 to

22.85)

£9.15 (0.00 to

22.85)

£0.59 (0.00 to

17.14)

£14.83 (0.00 to

62.32)

£1.09 (0.00 to

35.18)

Home safety inspections

Children’s centre costs £3.41 (0.00 to

15.33)

£0.20 (0.00 to

15.33)

£6.81 (0.00 to

30.66)

£0.44 (0.00 to

15.33)

£8.52 (0.00 to 30.66) £0.62 (0.00 to

15.33)

Fire & Rescue Service

costs

£13.63 (0.00 to

30.66)

£0.76 (0.00 to

15.33)

£13.63 (0.00 to

30.66)

£1.07 (0.00 to

15.33)

£22.14 (0.00 to

76.65)

£1.62 (0.00 to

15.33)

Other agencies £10.22 (0.00 to

45.99)

£0.61 (0.00 to

15.33)

£22.14 (0.00 to

45.99)

£1.42 (0.00 to

45.99)

£15.33 (0 to 45.99) £1.12 (0.00 to

15.33)

Complete data on costs available for 9 clusters per arm. The number of families represents the number of families with complete data within the 9 clusters

per arm.

*Possible outlier (reported 20 children’s centre staff + 5 Fire & Rescue Service staff providing a “fun day” (cluster 6, usual care arm))—when this cluster is

removed the mean is reduced to £254.25 with a maximum per cluster of £792.00.

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intervention arms were significantly more likely to report attending a fire safety session than

usual care arm families. However, in terms of the primary outcome measure families in either

intervention arm were not significantly more likely to report having a plan for escaping from a

house fire than usual care arm families. Economic analysis showed the IPB only intervention

was both less costly and more effective than usual care, whereas the IPB + facilitation was

more costly but also more effective than usual care.

Strengths and limitations

Our trial used a theoretically-based intervention. It measured a wide range of outcome and

process measures and used quantitative and qualitative approaches. This provided a good

understanding of what the intervention comprised of and how it may have achieved its impact.

Recruitment exceeded our required sample size; the attrition rate was consistent with the

Table 10. Cost-effectiveness analysis results for complete case and sensitivity analyses.

Usual care IPB only IPB + facilitation IPB only vs.

Usual care

IPB + facilitation

vs. Usual care

Complete case analysis

Number of families 151 140 123

Number of children’s centres 9 9 9

Mean cost per family (95% Credible interval (CrI)) £21.15 (3.95 to

38.31)

£12.65 (4.66 to

20.03)

£41.41 (31.58 to

52.41)

-£8.49 £20.26

Proportion with Fire escape plan (95% CrI) 0.48 (0.35 to

0.56)

0.49 (0.38 to

0.58)

0.48 (0.37 to 0.58) 0.03 0.02

Incremental cost effectiveness ratio -£275.31 £1007.96

Probability cost effective @ £200 (US$ 306) per additional

plan for escaping from a house fire

0.19 0.78 0.02

Probability cost effective @ £1000 (US$ 1531) per

additional plan for escaping from a house fire

0.22 0.53 0.25

Sensitivity analysis omitting outlying cluster

Number of families 151 140 123

Number of children’s centres 9 9 9

Mean cost per family (95% CrI) £14.99 (6.16 to

24.11)

£13.26 (4.52 to

22.24)

£39.97 (31.25 to

48.41)

-£1.74 £24.98

Proportion with plan for escaping from a house fire (95%

CrI)

0.47 (0.34 to

0.61)

0.50 (0.37 to

0.64)

0.48 (0.34 to 0.62) 0.03 0.01

Incremental cost effectiveness ratio -£53.01 £3778.55

Probability cost effective @ £200 (US$ 306) per additional

plan for escaping from a house fire

0.33 0.63 0.03

Probability cost effective @ £1000 (US$ 1531) per

additional plan for escaping from a house fire

0.27 0.53 0.20

Sensitivity analysis imputing for missing values

Number of families 370 369 373

Number of children’s centres 12 12 12

Mean cost per family (95% CrI) £19.21 (14.64

to 23.77)

£10.60 (6.48 to

14.73)

£43.01 (38.71 to

47.30)

-£8.60 £23.80

Proportion with plan for escaping from a house fire (95%

CrI)

0.44 (0.37 to

0.52)

0.44 (0.37 to

0.52)

0.58 (0.50 to 0.65) -0.00 0.13

Incremental cost effectiveness ratio £6447.53 £177.61

Probability cost effective @ £200 (US$ 306) per additional

plan for escaping from a house fire

0.02 0.60 0.24

Probability cost effective @ £1000 (US$ 1531) per

additional plan for escaping from a house fire

0.00 0.02 0.96

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sample size calculation and was similar across treatment arms. The majority of participants

were from the most disadvantaged areas hence our intervention was delivered to families at

higher risk of injury.

In terms of limitations, few participants came from a black or ethnic minority group or had

English as a second language. Outcome measures were self-reported and although we were

able to blind parents to treatment arm allocation, children’s centre staff could not be blinded;

hence this may have influenced reporting of some secondary outcome measures by children’s

centres. Further work is required to explore the possibility that the intervention increased fam-

ilies’ understanding and hence their reporting of plans for escaping from house fires. The trial

had three arms and multiple secondary outcome measures leading to multiple significance

testing, although we did pre-specify a single primary outcome measure. We did not adjust sig-

nificance levels to account for the three arm design or for having multiple secondary outcomes,

since there is no consensus on this and it has been stated that formal adjustments for multiplic-

ity usually complicate rather than enlighten.[36, 37] The significant results for secondary out-

comes should however be interpreted with caution. Finally, some families did not receive the

intervention and it is possible, therefore, that greater implementation may have achieved

Fig 2. Cost-effectiveness acceptability curves for the complete case analysis and without the outlier children’s centre.

https://doi.org/10.1371/journal.pone.0172584.g002

Community-based cluster RCT of the implementation of an injury prevention briefing

PLOS ONE | https://doi.org/10.1371/journal.pone.0172584 March 24, 2017 18 / 23

greater behavioural change. A recent national evaluation of children’s centres in the UK found

most children’s centre services were used by families for less than one year.[38] Under these

conditions it is difficult to achieve high levels of penetration of interventions.

Comparisons with existing research

The baseline prevalence of plans for escaping from house fires in our study was similar to that

in the US (52%), suggesting similar scope for improvement as in the UK. We were unable to

find any published evaluations of injury prevention interventions delivered in children’s cen-

tres in the UK with which to compare our findings. Sure Start Local Programmes (SSLPs) were

the forerunners to children’s centres. The national evaluation of SSLPs compared outcomes in

SSLP families with those in the Millennium Cohort Study living in similarly disadvantaged

areas without SSLPs.[39] At the age of three years, children in SSLP areas had a significantly

lower unintentional injury rate than those in the non-SSLP areas; this difference was not main-

tained by the time children reached five years of age. Consistent with our findings, this sug-

gests such services can impact on home safety outcomes for families in disadvantaged areas.

[40] There have been few evaluations of Head Start programmes in the US with injury preven-

tion as the focus even though children in the programmes are known to be at risk of injury.

[41, 42]

Children’s centres in the UK have been evaluated in a multi-component six year study (The

Evaluation of Children’s Centres in England (ECCE)). A survey of 5,700 parents participating

in ECCE [38] suggested few (8%) had received home safety advice from children’s centres. The

challenges of delivering evidence-based programmes within children’s centres were explored

in questionnaires and interviews with staff in 121 children’s centres.[43] Widespread use of

evidence-based programmes, particularly parenting programmes, was found. Education and

training are important, not only for parents, but also for those who care for children and influ-

ence children.[2] By introducing the IPB to children’s centre staff both the staff and parents

had exposure to evidence-based messages. However, as the ECCE study found, some children’s

centre staff “gave equal weight to research evidence and personal experience” and only a small

number of families were reached by the best evidenced programmes.[43] Similarly, we found

fewer than 50% of families received each key safety message and fewer than 20% attended fire

safety sessions.

Conclusion and recommendations

This research has demonstrated that children’s centres can effectively deliver evidence-based

injury prevention to families with young children who live in disadvantaged communities and

achieve changes in some home safety behaviours. The economic analysis suggested the IPB

only appeared to be most cost-effective, but this should be interpreted with caution as the

results were sensitive to missing data.

Choosing outcome measures for fire prevention programmes is difficult. Fire-related inju-

ries are uncommon events, and an extremely large trial would be required to evaluate the

impact of an educational intervention on reducing fire-related injuries. There is evidence that

some fire safety behaviours do reduce the risk of fire-related injuries and deaths, such as

smoke alarms.[5, 6] However, smoke alarm ownership is very common in the UK (more than

90% of families in our trial reported a fitted and working smoke alarm on every level of their

home at baseline), so demonstrating increases in functional ownership again requires large

sample sizes. Furthermore, those who don’t already have smoke alarms may be particularly

resistant to change, making only small effect sizes feasible to detect. We used fire escape plans

as the primary outcome measure for our trial and also measured component elements of fire

Community-based cluster RCT of the implementation of an injury prevention briefing

PLOS ONE | https://doi.org/10.1371/journal.pone.0172584 March 24, 2017 19 / 23

escape plans as a secondary outcome measure. Our finding of significant increases in the com-

ponent elements of a plan but not in fire escape plans per se, suggests further work is needed

to develop a valid and reliable measure of fire escape plans. Research demonstrating a reduc-

tion in risk of fire-related injury associated with having a fire escape plan would be helpful, as

would larger trials allowing detection of smaller, but clinically important differences.

The mode of intervention, through children’s centre staff rather than directly to families, is

typical of many health promotion programmes in practice. Our trial suggests less than full

implementation of the IPB, hence future studies should consider additional or alternative

implementation strategies.

What is already known on this subject?

Little is known about effective measures to reduce the risk of fire-related death and injury in

children other than provision of smoke alarms.

Children’s centres in the UK and Head Start in the US both have injury prevention as one

of their priorities.

Educational interventions can increase the prevalence of plans for escaping from house

fires although the effectiveness of children’s centres in delivering such packages is unknown.

What this study adds?

An Injury Prevention Briefing (an evidence-based educational package delivered by children’s

centres) can improve some aspects of families’ behaviours for escaping from house fires, e.g.,

making sure exits are clear.

The IPB only intervention was less costly and more effective than usual care, whereas the

IPB + facilitation was more costly but also more effective than usual care. These results open

the way for the development and evaluations of Injury Prevention Briefings for other types of

injury.

Trial registration

Trial registration: ClinicalTrials.gov identifier: NCT01452191. Date of registration: 10/10/

2011. ISRCTN trial identifier: ISRCTN65067450. Date of assignation: 06/12/2012. The first

children’s centre was recruited to the trial on 3/8/2011. The first parent was recruited to the

trial on 5/1/2012. Trial registration occurred after recruitment of some children’s centres as

the original protocol approved by the ethics committee did not include the word “cluster” in

the title and we wished to register the trial with this specified in the title. This required a proto-

col amendment and ethical approval for the amendment.

Supporting information

S1 Table. Full model for primary outcome (family have a plan for escaping from a house

fire) at 12 months follow-up.

(DOCX)

S2 Table. Analysis of variance table for primary outcome (family have a plan for escaping

from a house fire) at 12 months follow-up according to clustering by children’s centre.

(DOCX)

S1 Text. Technical appendix.

(DOCX)

Community-based cluster RCT of the implementation of an injury prevention briefing

PLOS ONE | https://doi.org/10.1371/journal.pone.0172584 March 24, 2017 20 / 23

S2 Text. KCS Non-IMP interventional trial protocol V1.

(DOCX)

S3 Text. PLoS ONE CONSORT extension for cluster trials checklist.

(DOCX)

Acknowledgments

The authors wish to thank the participating children’s centre staff and management and fami-

lies in Bristol, Newcastle, Norwich and Nottingham areas for their support in undertaking this

research. Without their help this trial would not have been possible.

The views expressed are those of the authors and not necessarily those of the NHS, the

NIHR or the Department of Health.

Previously presented

Multicentre randomised controlled trial evaluating implementation of a fire-prevention injury

prevention briefing in children’s centres. Public Health Science; EUPHA Conference 7th

European Public Health Conference, 19–22 November 2014.

Author Contributions

Conceptualization: DK RR EM MH MW CC NC AS.

Data curation: AK CC DK TD TG KB.

Formal analysis: TD AH AK NC CC AS GMN LM TG KB.

Funding acquisition: DK RR EM MH MW CC NC AS.

Investigation: TD AH JA GMN LM TG KB.

Methodology: DK TD AH MH NC CC AS GMN TG MW EM.

Project administration: JA AH GMN TG.

Software: NC AS.

Supervision: DK RR EM TD CC.

Validation: KB TG.

Visualization: AK TD CC DK.

Writing – original draft: DK TD NC AS MW JA CC GMN.

Writing – review & editing: DK TD AH AK MH NC MW JA CC AS GMN LM TG KB EM

RR.

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