Pregnant smokers who received the intervention and participated in the study were interviewed, first at around 16 weeks of pregnancy (n = 17) and again several weeks later (n = 8) or postpartum (n = 3). Interview schedules were informed by Normalization Process Theory (NPT) and Theoretical Domains Framework; interviews were audio-recorded, transcribed and analysed thematically, using the Framework method and NPT. Findings are grouped according to the four NPT concepts.
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Abkürzungen
BCT
Behaviour Change Technique
CO
Carbon monoxide
EDD
Expected Date of Delivery
IPiP
Improving Performance in Practice
NHS
National Health Service
NICE
National Institute for Health & Care Excellence
NPT
Normalization Process Theory
RPT
Risk Perception Tool
SSS
Stop Smoking Service
TCCC
Tobacco Control Collaborating Centre
TDF
Theoretical Domains Framework
Background
Smoking in pregnancy is associated with increased risk of serious adverse pregnancy outcomes such as miscarriage and stillbirth [1, 2], intrauterine growth restriction and low birth weight [3, 4]. In addition, there are other short and long-term health consequences for children born to mothers who smoke [5, 6] and significant annual costs to the National Health Service (NHS) for treating these mothers and their children [7].
A meta-synthesis of qualitative research on women who commence pregnancy as smokers has identified several reasons why some women struggle to quit [8]. Smoking in pregnancy is strongly socially patterned; women living in disadvantaged circumstances are more likely to smoke prior to pregnancy, and to find it harder to quit while pregnant or maintain a quit attempt postpartum [9]. This is due to the embeddedness of smoking in these women’s lives and how it shapes their social identities, making it more likely that cessation attempts during pregnancy will be seen as only temporary changes [8, 10]. Those who are successful are more likely to have support in quitting from close friends or relatives [8, 11, 12].
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The North East has the highest rates of smoking in pregnancy in England [13]. Shortly before this study began in 2012, rates of smoking amongst pregnant women were in excess of 20% [13]. Despite the introduction of National Institute for Health and Care Excellence (NICE) public health guidance 26, ‘How to stop smoking in pregnancy and following childbirth’ [14], midwifery services in the region had generally been slow to implement change [15‐17].
A protocol driven referral pathway, based on universal carbon monoxide (CO) monitoring at booking by midwives as part of routine care, which specifies thresholds for referral and actions to be taken
2.
Training of all midwives both in the use of CO monitors, thresholds and systems for referral, and also in delivering a brief intervention to encourage engagement with stop smoking services (SSS)
3.
Training of SSS advisors in giving effective advice to pregnant smokers
4.
Training of SSS administrative staff in effective customer relationship management techniques, in order to convert more referrals into appointments
5.
Additional contact from SSS at specified frequencies
6.
An intensive Risk Perception Tool (RPT), delivered by trained midwives following the dating ultrasound scan to smokers who have not engaged with SSS
7.
Branded materials and equipment, including CO monitors, to support the referral pathway, and training in stop smoking interventions for pregnant women
8.
Information systems to capture data on the implementation and delivery of the intervention package.
Thus, pregnant smokers would experience universal screening rather than discretionary selection by midwives, opt out (rather than opt in) referral into Stop Smoking Services (SSS) and higher levels of ongoing support, than had been previous practice. For those still smoking at the 12-week dating ultrasound scan, an additional intervention, the Risk Perception Tool (RPT) was delivered. During the RPT mother’s and baby’s carbon monoxide (CO) readings were displayed on a computer screen with the image of a baby changing from green, through amber to red and flashing, if readings were high. This RPT session also involved a midwife using a fetal doll to demonstrate the direct effect of smoking on the baby. On occasion, partners or relatives were present. For further details of the intervention see Bell at al. [16].
The overall aim of the evaluation, of which this study formed a part, was to determine whether a complex service reconfiguration improved the delivery of smoking cessation interventions to pregnant smokers, whether the reconfigured service could be implemented and sustained effectively, whether it cost-effectively resulted in improved pregnancy outcomes and whether it was acceptable to both health professionals and pregnant smokers. The effect of the intervention package on referral rates to SSS, quit rates and pregnancy outcomes (low birthweight for gestational age and preterm delivery), as well as the cost-effectiveness of the intervention (NHS costs per additional quit), is reported elsewhere [16], as is staff views of intervention implementation and prospects for normalization in midwifery and stop smoking services [17].
Maternity and SSS staff handed invitations to the women, allowing them to make contact with the researcher if willing to participate. In total, more than 185 invitation sheets were handed out by staff to women who had received the RPT, using an agreed script, whenever they had opportunity, including mention of financial compensation: a £50 high street voucher, to be given only on completion of two interviews. All pregnant women who responded to the invitation (n = 17) were sent an information sheet and agreed to be interviewed; their ages varied between 18 and 39 years (3 in their teens, 9 in their 20s and 5 in their 30s). Two were married, 15 had a partner, out of which 8 cohabited. All were of white British origin. All were smoking at conception, 9 (out of 17) were smoking at first interview; 11 participated in second interviews of whom 4 remained quit, 2 more quit and 5 remained smoking.
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Data collection
Interviews took place first at around 16 weeks of pregnancy and again prenatally (n = 8; 5–10 weeks between interviews) or postpartum (n = 3; 26–34 weeks between interviews), as determined by the time of recruitment and the end of the data collection period. The majority of the women were interviewed by SJ, who has clinical nursing and public health research experience, either at home or in community settings or by telephone, whichever was most convenient for the participant (Table 1).
Table 1
Setting for data collection
Method
Interview 1
Interview 2
Face-to-face
13a
4
Telephone
4
7
Neither
0
6b
INTERVIEW TOTAL
17
11
aHusband present in one home interview
bFive declined a second interview and one was recruited too late within the data collection cycle
A semi-structured interview schedule (Supplementary information 1) was developed in collaboration with our service user reference panel, covering CO monitoring, behaviour change, SSS, relationship with midwife and personal views/attitudes. Two frameworks of understanding underpinned questioning: Normalization Process Theory (NPT) [21] (Table 2), and the Theoretical Domains Framework (TDF) [22, 23]. Researchers used NPT to assess potential for normalization of the intervention in the study as a whole, and thought it would be interesting to use it to assess how pregnant women’s perceptions on acceptability affected normalization too. This was of interest because NPT is more commonly used with staff data. Health professionals’ understanding and implementation of the intervention are reported elsewhere [17]. The TDF draws together different theories - used to explain individual behaviour change - into one, cohesive format, making it useful in prompting interviewees to think about their feelings and choices associated with this intervention [22, 23]. Results from data analysis using the TDF will be reported elsewhere.
Table 2
Normalization Process Theory constructs
Construct
Definition
Coherence
The process of sense-making and understanding that individuals and organisations have to go through in order to promote or inhibit the routine embedding of a practice to its users. These processes are energized by investments of meaning made by participants.
Cognitive Participation
The process that individuals and organisations have to go through in order to enrol individuals to engage with the new practice. These processes are energized by investments of commitment made by participants.
Collective Action
The work that individuals and organisations have to do to enact the new practice. These processes are energized by investments of effort made by participants.
Reflexive Monitoring
The informal and formal appraisal of a new practice once it is in use, in order to assess its advantages and disadvantages and which develops users’ comprehension of the effects of a practice. These processes are energized by investments in appraisal made by participants.
First interviews lasted between 18 and 63 min (average 28), and second interviews lasted between 8 and 20 min (average 12). Telephone interviews tended to be shorter than face-to-face conversations; some women were inclined to talk at length, while others kept their comments to a minimum, although the reasons for these differences were not explored. Field notes were written up following data collection and throughout the study. Data saturation was not reached due to delayed roll out of the intervention and slow recruitment of participants. Interviews were digitally recorded with permission and subsequently transcribed verbatim by professional transcribers.
Data analysis
NVivo 10 software was used for data management. The data from pregnant women were inductively and thematically analysed (SJ) and nodes (n = 14) agreed through ongoing discussion (between SJ, JS and SH). Five nodes contained data relating to acceptability. Data in other nodes were excluded from this analysis as the research question focused on acceptability. These data were extracted, indexed and themed using a framework approach [24]. The data were then summarised, tabulated and used to create charts for each theme; then grouped to interpret the data as a whole, using NPT concepts. This rearrangement of the data under themes associated with acceptability to pregnant women is the basis for this paper (Fig. 1).
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Public and patient user involvement
In addition to the fieldwork as described above, the service user reference panel, which consisted of two groups, with three smokers in each, who were also mothers of young children, were convened to advise on such matters as the design of the research instruments, methods of recruitment and interpretation of the findings. Their input focused on increasing the effectiveness and accuracy of the evaluation in two main ways: by shaping service user recruitment methods and the language and content of interview schedules to serve as data collection methods with staff and service users. Working with the panel also increased researcher awareness of the issues from a public and patient perspective.
Results
Five main themes relating to acceptability of the intervention emerged, these were linked to NPT concepts: CO monitoring (Coherence); opt out referral process, receiving the stop smoking message (Cognitive Participation); experiencing benefit (Collective Action), and; follow up systems (Reflexive Monitoring) (Fig. 2). Quotes were chosen during Framework Analysis according to those which encapsulated the concept or idea or view most aptly. Those included in this paper were deliberately chosen from multiple participants.
×
Carbon monoxide monitoring
CO monitoring made sense (coherence) to smokers i.e. it was accepted, even expected after the first visit.
Interviewer: So what did you think about it when they first asked you to blow into the monitor?
PW: I was a bit sceptical at first cos I was thinking ‘God, what’s it gonna ... you know show up’, and then when it did show up it was like it hit home basically, to say you are not just doing damage to yourself, you are doing it to the baby, and it is just like, God, you don’t realise how much carbon monoxide you do actually intake.
Pregnant woman (PW52), Interview 1
It was expected by some women that CO readings would be taken at every maternity appointment, as well as any SSS appointments, and this was part of the intervention protocol. However, this did not always occur, variation in when and how frequently CO monitoring took place was reported by women. They said that sometimes smoking was discussed by midwives but without CO monitoring.
Interviewer: So did the midwife mention it [smoking] at your different appointments?
PW: No, I don’t think she has really. I think they did ask us, like have we still stopped, and when I says, aye, she said, that’s great.
Interviewer: Did they ever check your carbon monoxide again with the monitor?
PW: No, they didn’t.
Interviewer: Just left it really?
PW: Mmm.
Pregnant woman (PW68), Interview 2
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However, monitoring was consistently reported at the RPT, in follow-up visits by care assistants or the public health midwife and in SSS clinics.
Opt out referral process
Women engaged with the idea (cognitive participation) that midwife appointments at various stages in pregnancy (i.e. early bird, pre-6-8 week’s gestation; booking-in, usually 6–8 weeks gestation; RPT, 10–12 weeks gestation) or subsequent appointments, were used as opportunities to refer them to the SSS. Women reported that some midwives spent more time discussing smoking than others.
With regard to initial contact from the SSS, one woman reported attending appointments successfully:
I was only about nine weeks, I wasn’t very far along at all, but I think actually at the time I last spoke to you I wasn’t very keen on getting back in touch with the stop smoking services anyway, but with the help of the midwife as well, now I have had quite a few appointments with her, I did get back in touch with her [stop smoking advisor].
Pregnant woman (PW620), Interview 2
Another woman, where the opt out referral service model to the SSS included home visits from a midwife, identified less flexibility over appointment times and reported this made quitting harder.
(Partner of PW): And they make appointments at like three o'clock and that [school pick-up time].
PW: And six weeks [school] holidays … Because she'd come ... I said what day I was getting married and she wanted to come I think it was five o'clock the night before. I said you've got no chance, I'm sorry but no.
I don’t know, the way they got the information over, and the way they did it was what I needed, was the shock I needed to actually do it. If they’d done it softer with us I wouldn’t … . kind of would have just brushed it off.
… Yes, I am all over different hospitals because of different certain things, but no, I don’t get really feedback [about my attempts to quit smoking]. I get told off I think more when I go, when they check me with the midwife and the doctor.
Pregnant woman (PW52), Interview 1
Experiencing benefit
Women were motivated to act i.e. to quit (collective action), by CO monitoring and the RPT; although there was a sense of conflict.
I welcome it [the RPT] because it does scare you into ‘you need to stop’. But then, on the other hand, I know everyone is entitled to do their own thing, from the point of view they can have their own opinions. So it kind of pressurises people into, you have to stop smoking otherwise your breathing will be damaged or your breathing will have problems.
Pregnant woman (PW715), Interview 1
Women reported taking action when the intervention was linked to a professional discourse of caring and concern.
Well, she [the midwife] asked me if I smoked and I said yes, and then obviously she advised me of the dangers of smoking while being pregnant and stuff, and she referred me to the smoking [advisor] … She [the midwife] said to me, why don’t you speak to the smoking woman and if you don’t want to do it, you don’t want to do it. But it is worth speaking to her. And I am glad I did, because I had it in my head that I was going to pack in, but I didn’t have a date or anything. But then when I did speak to the smoking woman, I done it [set a quit date] the next day.
Pregnant woman (PW547), Interview 1
The RPT offered an opportunity for family inclusion within the stop smoking pathway, as partners/relatives were often present for the dating scan. Sometimes this led to results that benefited women and their wider families.
PW: … the second time [woman received stop smoking information e.g. at RPT] my partner was with me and so they were like showing him as well, why he needs to quit if he is going to be around me. Because it is not good for me, passive smoking and so on. I got it [stop smoking information] twice.
Interviewer: And what effect did that have?
PW: Well, he [husband] packed in [stopped smoking], so … .
Pregnant woman (PW547), Interview 1
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Maintaining personal autonomy within the decision-making process was essential for the experience of benefit.
I tried to do it with [first pregnancy] but just didn’t really do it. Like me head wasn’t in it to do it, do you know what I mean? So but this time I was like, right, I am set, I am doing it this time, so ...
Pregnant woman (PW547), Interview 1
Follow up systems
There was a variety of types and settings for on-going support with quit attempts. Women reflected on what they wanted: convenient, accessible, reliable services with high levels of support, especially in the early weeks of a quit attempt. Home visits, usually by care assistants, were popular. However, some women preferred attending SSS clinics and found them acceptable, although they did not receive such close support which, sometimes, they missed. Pharmacies were generally seen as a venue to pick up nicotine replacement therapy, and some women developed closer links here too. Features of pharmacies that were important to women included a caring attitude from staff, ease of access to SSS, mid–week support and flexible systems. Women chose the option they preferred within what was available, so unsurprisingly, for the most part, they reported favourably on their follow-up method.
Oh, it’s been dead good. The midwife [care assistant] that I have been seeing, the one who comes out to me about my smoking, has given me her number. She’s said that I can text her anytime that I feel like I need a tab [cigarette] or anything and she’ll like help us. She comes every week and she’s really nice.
Pregnant woman (PW715), Interview 1
Where some of these factors (convenience, accessibility, reliability) were lacking, they tended to discourage acceptability. Poor flexibility, a lack of monitoring and feedback, a loss of support beyond 12 weeks and a failure to deliver ongoing encouragement following efforts towards a quit, were all seen as damaging to continuing success at the quit attempt.
… when I missed the appointment I had no contact with any of them to say, I can’t make it, can I go to a different clinic, even like couldn’t I have made it on the Tuesday? But I had none of that, so I was kind of stuck in a boat where I thought, well, they are not kind of bothered and so I am not bothered.
The sheer difficulty of delivering system-wide change across organisations was also seen as challenging, but, in spite of these issues, when the resources were made available, the intervention was found to be effective and cost-effective [16], and women’s relationship with maternity staff did not seem to have been damaged, as initially feared by midwives when considering the implementation of NICE guidelines [14]. Indeed, there were specific benefits, including increasing opportunities for other family members to receive the stop smoking message, both in their homes and specifically during delivery of the RPT. Flemming et al. [8, 11, 27], in their systematic reviews, clearly demonstrate the significance of family smoking behaviours upon the pregnant woman, and how, without family support, especially that of partners, women were far less likely to quit smoking themselves.
These findings are supported by evidence for the effectiveness of Behaviour Change Techniques (BCTs), originally identified in the TDF, such as feedback and monitoring, social support, shaping knowledge, natural consequences, reward and threat [25]. Maternity and Stop Smoking Service systems are required which consistently enable the BCTs within the intervention to be delivered. The caveat to this general conclusion relates to the importance of context and circumstances. The way the stop smoking message is communicated by staff (motivational and caring), the systems and resources that back the pathway up, and the flexibility and range of follow-up options that are available to women in a specific location or Trust were all key factors in securing beneficial outcomes.
Within the NPT literature, it is unusual for the theory to be used with patients or individuals; principally, practitioners have been considered, most commonly in HCP teams [31]. However there are exceptions [32‐38]. McNaughton [38] has based her doctoral thesis at the individual, patient and HCP level. She found that NPT assisted in identifying the social influences and HCP attributes that affected patient responses to the offer of NHS Health Checks [38]. Anku et al. [39] similarly included patients, as well as practitioners and providers, in their study of combining tuberculosis and HIV services in Ghana. Understanding both the patient perspective and the environment at every level is critical in understanding the overall normalizing of an intervention [21, 40, 41]. The use of NPT to elicit patient perspectives and their influence on normalization is ripe for further study.
Our thanks go to Professor Eugene Milne and Professor Janet Shucksmith for supporting the study process throughout and to Pat Watson for conducting some interviews with participants and working with the service user reference panels, and to the six mothers on our service user reference panels. We thank the staff in the maternity and stop smoking services for facilitating access to participants, and to the pregnant women themselves, for giving us their time and effort. We are also grateful to Fresh, especially Martyn Willmore, for supporting the study. Lastly, we acknowledge the contribution of other members of the project team, Svetlana Glinianaia, Stephen Rushton, Andrew Close, Luke Vale, Eoin Maloney and Zelda van der Waal, for their contribution to the effectiveness study.
Ethics approval and consent to participate
Ethical approval for the process evaluation was given by Teesside University, School of Health and Life Sciences, Research Governance and Ethics Committee (Study number 038/13) and research and development approval was received from each NHS Trust and local authority according to their individual processes. Informed written consent to participate was obtained from all participants prior to interview.
Consent for publication
Not applicable.
Competing interests
Subsequent to this evaluation SJ has acted as an academic advisor to iPiP when preparing a manuscript for publication and has been remunerated for this work; she was also named on two bids in the same capacity. MWh is funded as Director of NIHR’s PHR programme. The other authors declare that they have no competing interests.
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