Condition category
Not Applicable
Date applied
16/10/2019
Date assigned
22/10/2019
Last edited
22/10/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Secondhand smoke exposure (SHSe), occurs when tobacco products are burned and then inhaled by those in the vicinity. There is no safe level of exposure and globally 1.2 million deaths are attributed to SHSe annually. Childhood SHSe has been causally linked with a number of childhood illnesses including respiratory tract infections and meningitis as well as associated with some childhood cancers. 39% of children in England whose parents smoke are regularly exposed to SHS in the home. Children who grow up with smokers are over twice as likely to become smokers themselves and regular smokers double their risk of premature death. The most effective way to reduce children’s SHSe is to support their parents to quit smoking. However, for parents who cannot or are unable to quit, there is a need to support families to change their smoking behaviours (such as to support them to make their homes smoke-free) to reduce the harm to children living in their household. Paediatric healthcare visits, such as an admission to hospital, may provide an ideal teachable moment (events or circumstances which can lead individuals to positive behaviour change) to initiate and/or deliver a SHS intervention to support families to reduce their children’s exposure to SHS. At the moment, little is known about the views of parents or healthcare professionals (HCPs) about the potential of using hospital presentation as an opportunity to initiate and/or deliver an intervention to reduce children’s SHSe.
The determinants of behaviour (capability, opportunity and motivation) will be explored from the perspective of the parents to gain an understanding of how the teachable moment can be capitalised on to instigate sustained behaviour change, as well as, from the perspective of the HCPs and how they can use the hospital setting to initiate and/or deliver SHS harm reduction messages to parents. The acceptability of approaches, content, and the delivery of interventions around SHS harm reduction will be explored from the perspective of all stakeholders. The study results will be used to guide the development of a future intervention to reduce SHS-related harms in childhood

Who can participate?
1. Parents/carers (aged >18 years) who have smoked in the home within the last 5 years and have presented with their child at Birmingham Children’s Hospital (BCH)
2. HCPs who have worked with parents and their children within the last 5 years at BCH

What does the study involve?
In order to understand the views of stakeholders on a secondary care initiated and/or delivered intervention to reduce children’s exposure to SHS a programme of research will be carried out including:
Discussions with up to 20 parents/carers who have smoked in the home within the last 5 years and present at BCH with their child to understand their views on using the hospital visit as an opportunity to support parents to change their home smoking behaviours.
Discussions with up to 25 HCPs who have worked with parents and children who are exposed to SHS at BCH within the last 5 years to understand their views on using the hospital visit as an opportunity to support parents to change their home smoking behaviours

What are the possible benefits and risks of participating?
This research may not directly benefit participants, but what they tell us may help us to better understand the perspectives of parents/carers who smoke (or have previously smoked) at home. We hope that we will be able use what we learn to explore ways the hospital might support families to change their home smoking behaviours.
There are no physical risks to taking part in this study. We do not anticipate that the interview/ discussion group will cause distress.

Where is the study run from?
Institute of Applied Health Research, University of Birmingham (UK)

When is the study starting and how long is it expected to run for?
November 2019 to December 2020

Who is funding this study?
Birmingham Children’s Hospital Charity (BCHRF519)

Who is the main contact?
Dr Laura Jones
L.L.Jones@bham.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Laura Jones

ORCID ID

http://orcid.org/0000-0002-4018-3855

Contact details

Murray Learning Centre
Institute of Applied Health Research
University of Birmingham
Egbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)1214143024
l.l.jones@bham.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS ID: 259460

Study information

Scientific title

A qualitative study to explore stakeholder views on children’s secondhand smoke interventions within hospitals

Acronym

PRECEDENT

Study hypothesis

To explore key stakeholder views and behaviour change opportunities for a hospital-based intervention around supporting parents to change their home smoking behaviours to reduce children’s exposure to SHS, informed by the COM-B model. This overarching aim will be addressed in two work packages (WP).

Work package 1a aims to use the COM-B model to explore parent/carer knowledge, attitudes, perceptions and acceptability of a hospital-based intervention to change their home smoking behaviours
a. To explore parental knowledge of SHS and experience of hospital contact around smoking behaviour.
b. To identify parental attitudes and perceptions towards receiving a hospital-based intervention to support them to change their home smoking behaviours.
c. To explore the perceived acceptability among parents of receiving a hospital-based intervention to support them to change their home smoking behaviours.

Work package 1b aims to use the COM-B model to explore healthcare professionals’ knowledge, attitudes, perceptions and acceptability of a hospital-based intervention to support parents to change their home smoking behaviours.
a. To explore HCPs knowledge of intervening around parent home smoking behaviours.
b. To identify HCP attitudes and perceptions towards a parent hospital-based intervention to change their home smoking behaviours.
c. To explore the perceived acceptability among HCPs for a parent hospital-based intervention to change their home smoking behaviours.

Ethics approval

Approved 05/09/19, East Midlands – Leicester Central Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; +44 (0)207 104 8234; NRESCommittee.EastMidlands-LeicesterCentral@nhs.net), ref: 19/EM/0171

Study design

Qualitative research study informed by the COM-B model of behaviour change.

Primary study design

Other

Secondary study design

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a copy of the different participant information leaflets used in this study

Condition

Smoking

Intervention

Work package 1a
Informed by the COM-B model, we will undertake qualitative semi-structured interviews and/or discussion groups with parents/carers who have attended BCH with their child and have smoked in the home in the last 5 years.
Whilst semi-structured and informed by WP discussion guides, interviews/discussion groups will be conducted in a participant-focused manner allowing experiences and views important to participants to emerge naturally. The overall aim of the discussions is to explore knowledge, attitudes and perceptions towards receiving a hospital-based intervention to support them to change their home smoking behaviours, as well as, whether they perceive this to be an acceptable time and setting for such an intervention.
Interviews/discussion groups will be digitally audio recorded, transcribed and then anonymised and checked for accuracy. Participants will be identified via advertising at the hospital site, social media such as Twitter and Facebook, the Trust website and via word of mouth (self-selected). Brief participant information leaflets will be available at reception desks and sent with appointment letters. Potential participants will always be approached by a member of their child’s usual care team in the first instance.

Work package 1b
Informed by the COM-B model, we will undertake qualitative semi-structured interviews and/or discussion groups with HCPs who work at BCH (or previously within the last 5 years).
Whilst semi-structured and informed by WP discussion guides, interviews/discussion groups will be conducted in a participant-focused manner allowing experiences and views important to participants to emerge naturally. The overall aim of the discussions is to explore their knowledge, attitudes and perceptions towards initiating and/or delivering an intervention to reduce parents’ home smoking behaviours as well as whether they perceive this to be an acceptable time and setting for an intervention.
Interviews/discussion groups will be digitally audio recorded, transcribed and then anonymised and checked for accuracy. HCPs at BCH will be contacted directly about the study through personal and professional networks of the research team members. This study will be advertised via posters in the hospital (i.e. staff rooms), on social media for example via Facebook and Twitter, the Trust intranet, and in email newsletters

Intervention type

Other

Phase

Drug names

Primary outcome measure

An understanding of stakeholder attitudes, beliefs and perceptions of a secondary care initiated and/or delivered intervention to reduce children’s exposure to secondhand smoke. Data (with the exception of a non-validated demographic questionnaire that will allow us to describe the sample of participants) will be qualitative in nature including field notes, audio files and transcripts. Participants will take part in a one off interview or discussion group lasting between 60 and 90 minutes.

Secondary outcome measures

N/A

Overall trial start date

01/11/2019

Overall trial end date

01/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Work package 1a:
1. Parent smokers who currently (or have previously within the last 5 years) smoked in their home
1.1. Whose children have presented at BCH in the last 5 years
1.2. Can speak English
1.3. Have the capacity and are willing to provide written, electronic and/or verbal informed consent and consent to audio recording of the interview/discussion group
1.4. Aged 18 years or over (restricted to coincide with the legal restrictions around tobacco smoking)

Work package 1b:
2. HCPs (aged >18) who work (or have in the last 5 years) at BCH
2.1. Provide services to non-smoking patients (children) who are exposed to SHS in the home
2.2. Can speak English
2.3. Have the capacity and are willing to provide written, electronic and/or verbal informed consent and consent to audio recording of the interview/discussion group

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Work package 1 (total n up to 45) We will seek to recruit (via a combination of interviews and/or discussion groups): up to 20 parents whose smoking in the home (or within the last five years) who present at BCH; up to 25 HCPs who work (or in the last five years) with children and their parents at BCH

Participant exclusion criteria

Work package 1a:
1.1. Parents who only use smokeless tobacco or e-cigarettes at home
1.2. Parents who have had a completely smoke free home for the previous 5 years or longer

Recruitment start date

01/11/2019

Recruitment end date

01/12/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Birmingham Women's and Children's NHS Foundation Trust
Birmingham Children’s Hospital, Steelhouse Lane
Birmingham
B4 6NH
United Kingdom

Sponsor information

Organisation

University of Birmingham

Sponsor details

Room 119 Aston Webb Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
012141447618
researchgovernance@contacts.bham.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Birmingham Children’s Hospital Charity

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The data collected as part of this study will be owned by the sponsor, the University of Birmingham. These data will be analysed, and a final study report will be prepared to a publication standard based on the collected data. This report will be submitted for publication in targeted journals. The final study report will also feed into a doctoral thesis, which will be publicly accessible in thesis archives. Furthermore, the results of this research may be used to directly inform future funding applications and proposals.
The study protocol will be prospectively registered online.
A final report will be prepared for the funders of the study, BCHRF.
Peer reviewed conference presentations and published paper(s): relating to stakeholder knowledge, attitudes and perceptions, perceived acceptability and determinants of behaviour change for delivering/receiving hospital initiated and/or delivered interventions to support parents to change their home smoking behaviours.
Insights into conducting multi-disciplinary research across different departments within BCH.
Research skills development and capacity building of a PhD student in the role of study co-ordinator.
Inform the development of a novel hospital initiated and/or delivered intervention to support parents to change their smoking behaviours.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Only the research team, the Sponsors relevant regulatory authorities, and the funder will have access to the final study dataset that will comprise a summary of the demographic characteristics of the sample and transcripts of interviews and/or discussion groups. Only once the main findings of the study have been accepted for publication or once EF’s PhD project is complete (whichever occurs first) will study data be made available to the wider community. When the overall PhD project is complete, all anonymised study data will be preserved for ten years in accordance with the University of Birmingham Code of Practice. The research team will consider external requests to gain access to anonymised data, to be securely shared under the auspices of the chief investigator (LJ, and always in accordance with the Data Protection Act of 2018 and the EU General Data Protection Regulation 2016/679). All requestors wishing to obtain study data will be asked to provide a brief research proposal including the objectives and timelines of the candidate project, intellectual property rights, and expectations for publications and citations. These details will form the basis of a Data Sharing Agreement between the University of Birmingham and the requestor, to clearly establish the responsibilities of each party. It is expected that requestors will, as a minimum, acknowledge the original research team and BCHRF funding, and will consider co-authorship of any subsequent publications, if appropriate. Permission for anonymised data to be shared for the purpose of future academic research will be sought from all participants via the informed consent form.

Intention to publish date

01/12/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/10/2019: Trial’s existence confirmed by East Midlands – Leicester Central Research Ethics Committee