Design

The intended intervention processes for the EARS intervention are described in Chapter 1. These were used as a basis for generating items for a checklist to assess intervention delivery and fidelity. Following a brief scoring-standardisation procedure, the checklist was applied to a purposive selection of consultation recordings and descriptive analyses were used to summarise the data.

A more detailed qualitative analysis, linking data from all of the above data sources (individual participant feedback with feedback from the HTs and the consultation recordings), will be conducted to examine the relationships between intervention delivery and smoking reduction and to refine the process model. However, this work is outwith the remit of the Health Technology Assessment (HTA)-funded research and so is not reported here.

Sampling frame

All consultation sessions were audio recorded subject to informed consent. Consent for this was taken on the main study consent form and this was checked verbally prior to starting the first consultation. A sample of four participants for each of the three HTs (12 participants in total) was selected to provide examples from early, late and in the middle of the study period (to smooth out any HT practice effects). For each client, three (out of a possible eight) consultations were selected for coding to provide examples of intervention techniques from early-stage motivation through to later-stage progress reviewing/relapse prevention.

Measures and procedure

To assess intervention fidelity (and at the same time quantify delivery in terms of predefined manualised elements), we used the Dreyfus system for assessing skill acquisition (Figure 5)⁹⁵ to score recorded consultations with respect to a HT’s skill in delivering each of the 12 intervention processes (see Table 31). A scoring checklist and instructions were developed and these are provided in Appendix 5c. The checklist was applied initially by three researchers with expertise in behaviour change (AT, TT, CGVS) to a sample of six consultations from two participants. Scores were compared and reasons for any discrepancies were discussed to produce a consensus about how to apply the scoring system.

FIGURE 5

The Dreyfus model of skill acquisition.

TABLE 31

Intervention fidelity scores for each process, with breakdown by trainer and by coder

Two researchers (TT, CGVS) then each scored consultation data from two participants for each of the three HTs (using three consultations per participant) to produce an overall intervention fidelity rating for each item and for each HT (see Table 31). This was done by listening to the set of (three) recorded consultations for each participant, reading the transcripts of the same consultations and then rating the fidelity for each item on the checklist. Because of limitations in time and resources, we did not conduct formal inter-rater reliability checks; this would have required both researchers to rate fidelity for around 20–30 participants each. However, we did split the coding for each HT between the two researchers, so that each researcher coded two participants for each HT. The average score for the HT is therefore the average of the scores given by two coders.

Analysis and interpretation

Descriptive data were extracted and reported to highlight areas of good or bad practice in delivering the intended intervention processes. Owing to the clear descriptions associated with each score (see checklist scoring instructions in Appendix 5c) and the steps taken to establish a consensus between coders on the approach to scoring, interpretation of scores is relatively straightforward. Scores of 0 or 1 represented poor delivery (or no delivery) of the intended process. A score of 3 or more was considered to represent reasonable quality of intervention delivery. Scores of 5 or 6 represented very high (expert-level) quality, which we were not expecting to see very often with our trainers delivering this novel intervention for the first time. It was accepted that for item 9 (seeking to identify and reinforce shifts in identity), the opportunities to deliver this process would be scarce and so a lower score (1.5 or more) was considered acceptable for this item. Item 12 (referral to smoking-cessation services) was scored as either 0 or 1 (yes or no) and so is reported separately.

Examples of good intervention practice were highlighted as the coders went through the consultation transcripts and these will be collated and used as examples in future training for the EARS intervention (either in their current form as audio recordings and transcripts, or by conversion into video example using actors to play the roles of practitioner and participant).

Recruitment and sampling

All trial participants had consented at baseline to being approached by an independent qualitative researcher to capture their experiences associated with the study and with the intervention, for those in that arm of the study.

During the delivery of the intervention, the research team regularly discussed the progress of individual participant progress and the nature of engagement with the intervention. We were particularly keen to identify intervention participants who appeared to have benefitted from the intervention and be examples of good practice, possibly for future use in training. As many participants as possible who engaged with the intervention were interviewed by TT.

Control participants were selected at random. Participants sampled were contacted by telephone and a convenient time to conduct the interview by telephone was arranged. No participants who were contacted declined to be interviewed. Verbal consent was obtained for the interviewed to be digitally recorded. All interviews were digitally recorded and transcribed verbatim for further analysis.

Interviews

Participants were interviewed within 16 weeks of completing the study. The interviews followed the guide shown in Figure 6 for control and intervention participants, respectively.

FIGURE 6

Generic and trial arm-specific interview guide.

Data analysis

Interview transcripts were analysed used the qualitative software package NVivo (version 9.2, QSR International, Southport, UK). The data were organised using a basic thematic analysis to provide a simple descriptive-level overview of the participants’ views and experiences. In-depth qualitative analysis procedures were not used here. However, these data will be analysed in more depth alongside the participant interviews and consultation recordings, using framework analysis⁶ to generate an integrated analysis of processes of behaviour change in the EARS intervention. This in-depth analysis will be reported as part of the PhD of one of the researchers (TT). The participant characteristics of those interviewed from both arms of the trial are shown in Table 32.

TABLE 32

Characteristics of participants who were interviewed at the end of the study

Clarity of invitation to take part in the trial

Targeting a population with expected low levels of literacy meant keeping the invitation as simple as possible without compromising the individuals’ understanding of what was being offered to them. Overall, the responses revealed a clear and concise understanding of what was being offered. For example:

TT:

So how clear was the information that you had?

Int:

Very. Very clear.

TT:

So how much did the information that you had read, how much did it match what you actually received in terms of the support and things like that?

Int:

Oh erm exactly . . . .

Female, aged 60–65 years, unemployed, moderate smoker, intervention

There were a couple of examples of where a participant reported misunderstanding, or elements of the study that surprised them. This included explanations of the requirements to wear an accelerometer, and confusion over the randomisation procedure:

Int:

The leaflet was kind of vague, it told you what it was actually based on but it didn’t tell you about you were going to get split into two groups. I don’t think it mentioned anything about wearing the accelerometer – was it called . . .?

Int:

No I didn’t know that, I thought ‘cause [the HT] rang up somebody else and they said, ‘You are in this section [trial arm],’ so I don’t know if they’d done any background research and said, ‘Well, she’ll be good in this group,’ or, ‘she’ll be good in that group’.

TT:

OK, right. So it doesn’t sound like that was explained to you properly then.

Int:

No, no not at all.

Female, aged 25–30 years, employed part-time, moderate smoker, intervention

Another example of confusion arose surrounding the payment for wearing and returning the accelerometer where the individual thought that rather than them getting paid for wearing and returning it, they had to pay the study. [Note: during the course of the study, a number of accelerometers were not being returned so we increased the reward for returning them from £10 to £30 in exchange for wearing it for 1 week and returning it].

Int:

Yeah, well, because [the HT] hadn’t mentioned it at the beginning, so I didn’t know anything about it, and then when it had been changed [the HT] said, ‘Oh, just to let you know that it’s gone from £10 to £30’. And I thought that I had to pay her and [the HT] said, ‘Why?!’

TT:

So that wasn’t made very clear to you.

Int:

No!

Female, aged 30–35 years, unemployed, moderate smoker, control

While this may demonstrate a high level of motivation for taking part in the study, it suggests that explanation of the reimbursement structure and randomisation may need a clearer explanation. This was the first time that most participants had engaged in a research trial and more practical explanations to participants of the need for and process of randomisation are suggested by these findings.

Appeal of the invitation and support for reduction

The novel approach of actively promoting support for reduction in smoking was shown to be well received by the majority of the sample. Many framed the appeal of reduction against the alternative of stopping abruptly. The appeal of reducing appeared to stem from an underlying desire to change behaviour but, owing to a lack of confidence in stopping abruptly, reduction seemed like a much more manageable approach to tackling their smoking behaviour:

Yeah, I think yes, I think that was probably it, the reduction thinking. Well you know, rather than sort of go cold turkey and completely stop I thought, ‘Oh you know, you could help me reduce it,’ which you did, so you know that obviously it worked.

Female, aged 60–65 years, unemployed, moderate smoker, intervention

TT:

What was it about that then that appealed to you?

Int:

Erm [coughs] it’s easier than cutting it out altogether, I guess it should be easier actually. But . . . well I needed to try something as opposed to nothing, that’s what appealed to me.

Male, aged 60–65 years, unemployed, moderate smoker, intervention

Well it . . . I didn’t feel as if I was undermined in any way you know, until it’s to stop altogether you know. I felt that it was, well, maybe an easier solution.

Female, aged 60–65 years, employed full-time, moderate smoker, intervention

One individual explicitly expressed this notion as reason for coming into the study, revealing that cutting down would be a good idea at a time when they feel they are not ready to stop:

TT:

Cutting down, is that something that perhaps appealed to you?

Int:

Yeah it did as well, because I thought, ‘I don’t really want to, I am not ready to stop yet,’ and I thought cutting down is quite good. I tend to smoke if I am a bit stressed. I use it as an excuse to smoke so [laughs] I thought, ‘You know, that’s quite a good way to do it really is just cut down bit by bit’.

Female, aged 35–40 years, employed part-time, moderate smoker, control

For some, past experiences of failed quitting heightened the appeal of support for reduction as a novel approach to tackling their smoking behaviour:

Well, for three or four years I’ve been trying to give up smoking [and] last month [I] done ten months, and then I had a smoke. The year before six months, the year before that was four months, and it’s always a quit, you know, stop, go on to nicotine gum and lozenges and patches and whatsoever. This one appealed to me because you cut down, you know, every week you cut down two cigarettes a week and you just cut down and cut down and I eventually got down to none.

Male, aged 60–65 years, unemployed, moderate smoker, intervention, successful quitter

The message of support to cut down, in the trial invitation, did not appear to threaten people’s sense of control over their own behaviour compared with a message around abrupt quitting. For some, it was clear that a pervading message of the need to ‘stop smoking’ would have completely alienated them from engaging in the study:

Well, [the HT] said to me, ‘We are not here to make you stop smoking, make you stop smoking. We are here to at least try and cut you back, if we can help you just to cut down, cut down by whatever, just to help you cut down, we are happy with just helping you cut down.’ And I thought, ‘Well, this is someone talking to me that’s not saying, ‘We can stop you smoking. We can do this,’ ’ but [the HT] was saying, ‘We can help you to cut down. We may in time be able to stop you smoking,’ and I said, ‘Well, that’s a very sensible attitude to take,’ because someone telling me, ‘I’m going to stop you smoking,’ I’d tell them to . . . go away! So that’s what made me do it initially, because they weren’t threatening me that they could stop me smoking. But even at this time, there is no one that can tell me, ‘I can stop you smoking,’ you know what I mean?

Male, aged 55–60 years, unemployed, heavy smoker, intervention

There was also evidence to suggest that smokers can feel saturated and alienated by the ‘hard sell’ of the abrupt quit message. The invitation was designed, as was the intervention, to be supportive and client centred and a step away from traditional services, and the supportive and pressure-free nature of the invitation was well received:

You know, I say, when [the HT] gave me the leaflet I thought, ‘Yeah, all right, I’ve heard all this before,’ and I thought, ‘Well, here we go with the hard sell’. But [they were] totally different. [They were] so relaxed, so friendly, and that’s what pushed me towards it. If [they] had tried to come across with the hard sell I would most probably have just ignored [them] and said cheerio. But I think just approaching people in a friendly manner . . . I mean, sometimes it helps.

Male, aged 55–60 years, employed full-time, heavy smoker, intervention

Oh, I expected the trial to be like, ‘Oh, you’ve got to do this, you’ve got to do that,’ you know! And it wasn’t nothing like that because I said to my chap, I said, ‘If I go down there and they say, ‘You’ve got to give up smoking now,’ I’m saying no, I can’t do that!’ But [the HT] wasn’t nothing like it, [the HT] was really nice. I said to her, ‘I can do what I can do.’ I said, ‘You can set me out some tasks and I will try and do them.’ So that’s what [the HT] done for me.

Female, aged 50–55 years, employed full-time, moderate smoker, intervention, failed quitter

The intention of providing a supportive and pressure-free message seems to have been achieved and effective in engaging with the targeted population.

For one individual, they recognised both the reduction and the PA support side of the intervention as being something they would like to take advantage of:

I was actually thinking about doing something to help myself so when it came up and then it said about the smoking reduction I thought it was like a bonus that I can get healthy and reduce my smoking at the same time.

Female, aged 25–30 years, employed part-time, moderate smoker, intervention

This was a relatively isolated case in responding to the appeal of the invitation, but this was to be expected due to the intentional ‘down-playing’ of the PA side of the intervention in an attempt not to alienate the less active, or to recruit only those most interested in PA.

Effect of invitation

It became apparent that the invitation itself had a motivating effect on people’s desire for change. As was expected, most smokers were already contemplating, and had been for some time, the idea of changing their smoking behaviour. The invitation acted as a prompt to change their smoking habits:

Oh exactly, exactly, it actually gave me the push that I needed [laughs] just getting the letter and then, you know, yeah it just gave me the kick that I needed. I’d been thinking about it for a long time but never doing anything about it. As I say, the first getting the letter was the kick that I needed. I mean I could really have stopped in the next couple of years, I don’t know about that one but I hope I would have done, but it was just that initial for the letter coming through the door and I thought, ‘Yeah, I would do that’.

Female, aged 60–65 years, unemployed, moderate smoker, intervention

Um, well, because I recently tried to give up smoking a few months before I started and obviously it didn’t happen, but I was on the smoking replacement stuff, and I just thought, ‘You know, I’ll give anything a try,’ if you know what I mean. So when I got the letter I just thought, ‘Oh yeah, I’ll go for that’. You know, it was just something that I immediately thought, ‘Yeah, I want to do it’.

Female, aged 35–40 years, employed part-time, moderate smoker, intervention

Motivations for taking part

Not surprisingly, a common motivation was health related, either through personal health or through ill health of family or friends. Although there is little evidence to suggest that cutting down smoking has significant health benefits, it was perceived by people to offer health benefits with quitting still an underlying long-term goal:

Because I have had a few friends who have died of cancer and that recently, see? So it’s getting more of a thing to, like, try [cutting down].

Male, aged 45–50 years, employed full-time, moderate smoker, control

Because I keep on having a permanent cough and it won’t go away. And the doctor has given me this, that and the other but he said, ‘Your cough ain’t going unless you give up smoking’. So it really is . . . it irritates my throat and that’s why I cough all the time.

Female, aged 50–55 years, employed full-time, moderate smoker, intervention, failed quitter

Oh, I’d been thinking for about a year I must give up smoking, it’s expensive and it’s not healthy, it’s antisocial and you know, all these things, but never quite doing anything about it.

Female, aged 60–65 years, unemployed, moderate smoker, intervention

The last person also mentioned the financial cost of smoking as a motivating factor, a motive that was borne out in other dialogues:

TT:

So you weren’t necessarily interested in quitting altogether, but just the idea of reducing was quite a good idea for you, was it?

Int:

Yeah, I was averaging about 20 a day and being on a pension I went over it and I thought, ‘This is getting too expensive. I am going to have to knock it on the head’.

Male, aged 60–65 years, employed full-time, heavy smoker, intervention, successful quitter

Unsuccessful and negative previous experiences of using NRT and other medicinal therapies emerged as a strong theme linked positively to motivation for taking part. It was envisaged that the intervention would offer a novel alternative to the use of NRT, and people’s description of past experiences seemed to confirm this particular aspect of the intervention.

Umm [sighs] well I suppose the fact that I’d been on the 3-month course [varenicline] . . . I started smoking again [on holiday] and when I got back and this cropped up I thought, ‘Well you know, anything I can do to help,’ you know, ‘stop people smoking including myself,’ I thought, ‘Well I’ll take part in it,’ you know and whether it was going to be of any use to me personally or not at the end of the day I thought I’d just wait and find out.

Male, aged 55–60 years, employed full-time, heavy smoker, control

Oh I’ve tried a couple of times to cut out smoking totally ‘cause I’ve tried the smoking aids and all the things you know, the puffer and the patches and that hasn’t worked, so I thought, ‘Oh well, I’ll give this a try then try and cut down,’ yeah.

Male, aged 40–45 years, employed part-time, very heavy smoker, intervention

There were a couple of reports of people taking part through altruistic motivation and the interest of being part of a research study:

I just thought I’d see. I don’t know, it just sort of appealed really, and also I suppose out of interest of a scientific enquiry.

Male, aged 45–50 years, employed full-time, moderate smoker, intervention

Well, I’m up at the uni anyway, and helping out with studies is a good idea.

Female, aged 30–35 years, unemployed, moderate smoker, control

There was an isolated example of somebody coming forward to enter the study because of the incentives offered to the intervention group in terms of subsidised leisure facility access:

Well obviously I thought I might be one of the lucky ones that would get the support, obviously they had gym membership and obviously I was still wanting to do all of that as well so, and obviously where I am it costs too much a month to actually go to the gym, so . . .

Female, aged 35–40 years, unemployed, moderate smoker, control

It appeared that some participants were only taking part for the financial incentive offered for returning the accelerometer:

Well, I’m not sure. I mean, I’ve spoken to a few people who’s been on it and when it was first mentioned, somebody said, ‘Oh you get £30 at the end of the 3 months.’ I said, ‘So you did it for the £30?’ He said, ‘Well, yeah.’ I said, ‘Well, how sad is that? That’s really sad. So are you going to pack up smoking?’ ‘Oh, no.’ You know, which I think is rather sad. I would just cut out the incentive of any money.

Male, aged 55–60 years, employed full-time, heavy smoker, intervention

We are also aware of one participant who withdrew because the financial incentive was ‘not enough’.

Randomisation: understanding the process and acceptability

Participating in a RCT was a new experience for the majority of the participants. With the exception of the one example discussed earlier, the procedure was well understood by those interviewed, albeit explained and understood in a variety of terminology:

[The HT] said to me that there’s going to be two groups and after we’d had the discussion about the whole thing, they [phoned] somebody in Exeter and they would allocate me to a particular group.

Female, aged 50–55 years, employed full-time, moderate smoker, control

Yeah, yeah. No, the person who was mentoring me at the time, he said, ‘You may be lucky, you may not. It depends’.

Male, aged 60–65 years, employed full-time, heavy smoker, intervention, successful quitter

The effect of the randomisation procedure on motivation to remain in the study (reluctance to remain in the study if not receiving any support) showed no particular influence either way. Some people showed no disappointment in being allocated to the control arm, while some did:

TT:

Right, and how was that for you? Was it a disappointment or was it . . .?

Int:

No, no, not at all, no, it was fine. I was just interested to see what would happen actually!

Female, aged 50–55 years, employed full-time, moderate smoker, control

Yeah, I was a bit gutted by it but like you say, they did explain to me beforehand that that may be the case.

Male, aged 25–30 years, unemployed, heavy smoker, control

The HTs also revealed that participants were on the whole ‘disappointed’ to be allocated to the control condition, with one participant immediately withdrawing from the study as a result.

Locality of assessments

Assessments took place in a centralised and well-known health service building and, where appropriate, at the participant’s GP surgery. From those interviewed there were no complaints about the location of sessions.

One of the successful quitters in the study praised the location of the sessions as the SSS was based in the same building, and so when he did decide to make a quit attempt the process was relatively seamless. Only two of the quitters did make use of the SSS, so this was not relevant for many participants.

Yeah. I would just like to mention that at the [centre] where it was held, to actually stop smoking and then getting the nicotine aids things, it’s made a damn sight easier because you are in the hospital and they have got a non-smoking unit there. So I saw this [stop smoking advisor], prescription, straight away, for gum, nicotine gum, patches and all the rest of it, you know. Because the location is brilliant because you did not have to go away and find somewhere, go to my surgery.

Male, aged 60–65 years, unemployed, moderate smoker, intervention, successful quitter

Intensity of support

Behavioural support for helping people who do not want to quit in the immediate future to cut down is a new area of research and little is known about the amount of support required. A major consideration was the frequency, duration and length of time over which the support should take place, and the mode of delivery. The pre-pilot development work resulted in a very flexible style of intervention delivery, with a mix of face-to-face sessions and telephone support sessions.

There was support for weekly sessions, which some participants found to be acceptable:

Oh no, no that was fine. I think once a week was brilliant and that’s what’s helped me.

Male, aged 60–65 years, unemployed, moderate smoker, intervention, successful quitter

I think it was probably about right, I don’t think, you know, it didn’t seem onerous particularly being part of the study.

Male, aged 45–50 years, employed full-time, moderate smoker, intervention

Well I think I, all the ideas were there but you know I thought it was probably enough.

Male, aged 60–65 years, unemployed, moderate smoker, intervention

No, it was just right, I saw [the HT] on a Tuesday morning at 10 and I was more or less out of there by 11, just before. Yeah, no, I was happy with that, that was fine.

Female, aged 35–40 years, employed part-time, moderate smoker, intervention

The lengths of the sessions were generally acceptable as well:

No, I think it was OK. It was mostly an hour a week, sometimes it went a bit longer, but no it was fine.

Male, aged 40–45 years, employed part-time, very heavy smoker, intervention

The mixture of face-to-face contact and telephone support was generally well received by those interviewed, allowing for increased flexibility and engagement with the support around continually changing circumstances for some:

[The HT] always used to ring me. Because some days I couldn’t make it and I just said to [them], ‘Can I speak to you on the phone instead?’ And then we’d do the paperwork over the phone because I was working quite a bit then.

Female, aged 50–55 years, employed full-time, moderate smoker, intervention, failed quitter

Having the telephone contact appeared to play an important part of the perceived support participants experienced, whether or not they used it, having been provided with the HT’s telephone number and being told they could always telephone if they had any problems.

I always had the mobile number anyway, not that I needed it, but they said you know whenever I did need it for anything.

Male, aged 40–45 years, employed part-time, very heavy smoker, intervention

I think it worked really well because I always had [the HT] on the other end of the phone, if I needed her, do you know what I mean? You know, [the HT] was always there for me and so they really helped me a lot.

Female, aged 50–55 years, employed full-time, moderate smoker, intervention, failed quitter

No, no it was fine it was fine. I mean when, well, they were always there at the end of the phone whoever you were dealing with, that was quite nice, if you had to change an appointment or what have you they were always there.

Female, aged 60–65 years, employed full-time, moderate smoker, intervention

The overall feeling regarding the intensity of the intervention was generally mixed. There was no report from those interviewed that the support was too intensive or overbearing, but there was a recurring theme that the support could have been more intensive than once a week:

Maybe erm a little more often to see somebody. I mean as I say I was fine, but maybe some people would like that little bit more . . . even a phone call maybe just to see how you’re getting on [in between sessions].

Female, aged 60–65 years, unemployed, moderate smoker, intervention

We were doing regular meetings but I found if there had have been a little bit more contact like maybe just a phone call like halfway through the week . . . I think as well the weekly meetings maybe like a midweek telephone call to give you that little bit of encouragement and everything.

Female, aged 25–30 years, employed part-time, moderate smoker, intervention

Some participants reported that not only was the support not intensive enough, but it could have gone on for longer to support further behaviour change:

I would say the only thing is, I mean like now I’ve done it and everything, it was too short and it wasn’t intense enough . . . I mean, [the HT] was excellent and I am personally saying my idea is that if it was more intense it would be more helpful. It would be better.

Male, aged 55–60 years, unemployed, heavy smoker, intervention

Erm I think . . . if you got people to give up smoking I think it would be, you know, a longer period of time would be better.

Male, aged 60–65 years, unemployed, moderate smoker, intervention

There was some evidence to suggest that participants were not receiving the weekly level of support that was intended.

Well, when I say that, without being rude, I mean . . . my counsellor was very good but I saw [them] once every few weeks, of a couple of weeks maybe or maybe I saw [them] like next week, then I wouldn’t see [them] for two weeks, or three weeks maybe, or two weeks, you know what I mean?

Male, aged 55–60 years, unemployed, heavy smoker, intervention

There was a period when it was sort of four, eight and sixteen weeks was it I can’t remember what the time was but erm, yeah, maybe say every two weeks would have been helpful to some people.

Female, aged 60–65 years, unemployed, moderate smoker, intervention

Some instances of limited contact were due to staff illness, the three HTs all working part-time and on different days, and HTs being fairly rigidly assigned to individual participants (to maintain continuity). Field and meeting notes did reveal a large variability in participants’ abilities to stick to regular scheduled meetings depending on unpredictable and changeable personal circumstances. One participant withdrew from the study before receiving any intervention support sessions due to a delay between the baseline assessment and the first intervention session. Fortunately, these difficulties were few and participants generally appreciated the intensity and flexibility of support received.

Style of delivery

The EARS client-centred intervention was designed to maximise adherence among a traditionally service resistant group. The HTs were trained to establish a strong rapport and engage participants in taking control of any behaviour change. We were keen to understand how this worked and was perceived by participants.

There was good support for the HTs and the strong rapport they developed with the participants interviewed, with discussions around the targeted behaviours moving forwards in an individualised way.

Yeah, fine. [The HT’s] all right. Yeah, [they’re] lovely. I used to go down and see them or they used to ring me if I was too busy at work or something. Yeah, they was fine. I got on really well with them. They was a good help.

Female, 50–55 years, employed full-time, moderate smoker, intervention, failed quitter)

But [the HT] was very good at what they done, you know what I mean? [The HT] was, I mean, like first, like most people with a doctor or something like that, ‘How are you feeling? How’s your problem?’ Well with [the HT], with their consulting ways, it was like, ‘How’s your week been? Have you had a good time? Did you do anything?’ then you had a 5-minute chat, only about basics like, you know, blah blah blah, and then slowly they brought in the smoking, you know, and what I was doing and the conversation. They was very good at what they done.

Male, aged 55–60 years, unemployed, heavy smoker, intervention

[The HT] was a brilliant help, [they were] fantastic to be honest.

Male, aged 45–50 years, unemployed, heavy smoker, intervention

The skill of the HTs in developing and maintaining good relationships with the participants was widely acknowledged among those interviewed. Advanced interpersonal skills were a high priority for the appointment of the HTs within the trial and they appeared to be effective:

Well I mean, there was never any question, you know, it was always like, ‘You know it’s down to you,’ you know, so no, I found it, you know . . . really quite good actually you know, I thought they were there was no question but lots of support I guess, and interest.

Male, aged 60–65 years, unemployed, moderate smoker, intervention

[The HT] said it was entirely up to me, what I was doing, and yeah, they were a good help, that’s all I can say, really. [The HT] was a good help.

Female, aged 50–55 years, employed full-time, moderate smoker, intervention, failed quitter

Int:

Oh totally, like my decisions, I wasn’t pressurised into it at all. I was encouraged and I was supported but I wasn’t pressurised.

TT:

Did you feel like you were in control of your decisions then about how much to cut down?

Int:

All the time, yeah, all the time.

Female, aged 60–65 years, unemployed, moderate smoker, intervention

Oh yeah, I was in control. I mean, I told [The HT] how many I was going to cut down a week or a day and they said, ‘OK, well that’s the goal you are going for.’

Male, aged 60–65 years, unemployed, moderate smoker, intervention, successful quitter

Oh no, not at all, [the HT] gave me some useful, like, suggestions and how to plan what I was going to do. But no, [the HT] was never like suggesting, ‘You are going to do this, you’re going to do that,’ no, never like that, no.

Female, aged 25–30 years, employed part-time, moderate smoker, intervention

Participants experienced a very client-centred style of delivery, one which was not threatening and placed them firmly in control of the decision-making process. There was also repeated evidence of people responding well to the strongly supportive and non-directive nature of the intervention delivery:

Well, no one likes people telling them what to do really, do they, unless it was discussed, so it was a study about me and my smoking habits then obviously it’s got to come from me and not someone else, ‘cause everyone’s different ain’t they with smoking and everything.

Female, aged 25–30 years, employed part-time, moderate smoker, intervention

It’s all down to the person but as I say, I’m not weak-minded and people can’t tell me to stop smoking but [the HT], the way they put things across to me, explained things, and, you know? They brought me down to earth in a nice way.

Male, aged 55–60 years, unemployed, heavy smoker, intervention

[The HT] was just, you know, not advising me but . . . [the HT] wasn’t even telling me, [the HT] was just saying, ‘You do what you think best,’ and ‘Do what you can do,’ they said. But they did say to me to get out a bit more because I never did go out very much. No, it was from me. They didn’t force it on to me, they just advised.

Female, aged 50–55 years, employed full-time, moderate smoker, intervention, failed quitter

Yeah, I mean, it was advice, it was good advice. [The HT] used to say, ‘We are not pushing you to stop smoking, but if you want to cut down, this is the ways you can do it.’ I had the forms each week down there each time like, and it was always good advice, it was always pleasant. There was no hard pressure, no hard sell.

Male, aged 55–60 years, employed full-time, heavy smoker, intervention

TT:

I wonder how well would the intervention have worked if it was a bit more directive?

Int:

Yeah I, yeah I probably wouldn’t have reacted you know in the same way, yeah. Because I think it’s something, it’s nice to talk to somebody one to one but at the end of the day it’s yourself that must be in control and be able to say, you know, ‘Well yeah, this is okayOK, I can do this,’ or, ‘I can do that,’ but what do you know sort of to be told that you should be do this, you should do that, because it’s up to each and every one of us to decide.

Female, aged 60–65 years, employed full-time, moderate smoker, intervention

Key to promoting ownership and supporting people in taking control of their own behaviour change is eliciting the individuals’ own solutions to problems. The HTs mostly prompted participants to reflect on behaviours and consequences, and identify solutions:

Yes I did, yes, and as I said you know you didn’t, they weren’t intrusive, they weren’t saying, ‘You must do this,’ or . . . they were helpful and just made suggestions, but it’s probably things that you would have thought about yourself but their suggestions were what you were thinking really, you know, the ones that reacted, but it was nice to know that they weren’t sort of saying, ‘Well you should do this, you should do that,’ you know, it was a one-to-one thing, it was very good.

Female, aged 60–65 years, employed full-time, moderate smoker, intervention

Support was voiced for the non-judgemental nature of the intervention, which was designed to avoid failure and always reframe any failures as learning experiences or opportunities for reflection:

The next fortnight that I saw [the HT], they said, ‘How did you get on?’ and I showed them the sheet and they said, ‘Well, you kept to your goal.’ And that was it. They didn’t tell me off a lot or belabour me or . . . I did try and keep to my goal [but] a couple of days I missed out, you know.

Male, aged 60–65 years, unemployed, moderate smoker, intervention, successful quitter

Yeah I think, you know, there wasn’t, I didn’t have any sort of great pressure or anything, you know, I mean there was no, ‘You are a bad person, you must quit,’ sort of thing or attitude if you know what I mean.

Male, aged 45–50 years, employed full-time, moderate smoker, intervention

One participant favourably compared the different approach with other support they have received in the past:

I wasn’t told, you know, ‘You should be doing, this you should be doing that,’ like when I have, when I’ve gone to other places to try and give up smoking [laughs] yeah, ordered to do things, you know what I mean, we just talked about things, talked about ideas.

Male, aged 40–45 years, employed part-time, very heavy smoker, intervention

Multiple behaviour change

Fundamental to the intervention structure was its aim of addressing two behaviours simultaneously, an approach that is not widely advocated in behaviour change literature, and in most cases avoided, for those wishing to quit. The complementary nature of the two behaviours (one a ‘stopping’ and one a ‘starting’ behaviour) meant that it was postulated that addressing the two behaviours alongside each other could be acceptable.

Resulting from the pre-pilot work and work with early intervention participants, the behaviours were introduced sequentially with smoking behaviour taking precedence over PA behaviours. How acceptable this was to participants and how much they engaged with the idea was of particular interest, especially how they viewed the utility of using PA to influence their smoking behaviour.

While it was difficult to explicitly elicit from participants how difficult or challenging they found it to try changing two behaviours simultaneously, there was qualitative evidence that participants actively engaged in the process of using PA as a way of managing and influencing their smoking habits:

I did make some changes, yeah, and when I do go out for a walk with the dog I don’t take my cigarettes with me and I could be out for hours, so I don’t bother taking my fags with me.

Female, aged 50–55 years, employed full-time, moderate smoker, intervention, failed quitter

Well, there was the exercise thing, getting out and being more active and stuff, which I am quite an active person anyway. I walk everywhere and you know, I am not a sitty-home person. I might want to do it once a week but I’m sort of like an active person anyway. Yeah, things like that helped me. You know, the gym helped.

Female, aged 35–40 years, employed part-time, moderate smoker, intervention

Physical activity was important in highlighting the negative health consequences of smoking and this appeared to change the way some people thought about their smoking habits:

As I say, doing exercises and that, you feel healthier and then obviously if you are doing exercises and silly things like that, you feel healthier and then when you go to put a cigarette in your mouth, it’s obviously psychological, you’re going, ‘Oh no, I am wasting myself going in the gym for that hour,’ if you know what I mean, ‘to go and have a cigarette now’.

Male, aged 55–60 years, unemployed, heavy smoker, intervention

There was also support for an ‘identity shift’ from a smoker to an exerciser, and the value attached to being active:

Yeah, well as I say, it did help and not only that, you see, getting confident was . . . in this gym, it was state-of-the-art, you know, I tell you if I was still smoking there is no way I could use some of those machines that I’ve been using, the rowing machine and the boxing machine thing. No way I could use those if I was smoking! I’d just be coughing my lungs up.

Male, aged 60–65 years, unemployed, moderate smoker, intervention, successful quitter

And I found out it’s a drug in a way ‘cause when you go to a gym you come back out you feel great for it and then smoking, you don’t even think about smoking ‘cause you’ve gone in there and you’ve done like an hour and a half workout, the last thing you want to do is come out and have a cigarette.

Female, aged 25–30 years, employed part-time, moderate smoker, intervention

Physical activity was an acceptable way for some of distracting themselves from smoking and coping with the cravings:

Erm, well it’s still difficult to cut down the cigarettes I’ve got to agree, but if I walk more then I don’t need to, you know, I don’t want to smoke, put it that way.

Female, aged 60–65 years, employed full-time, moderate smoker, intervention

Well, I get about a bit more now because I never used to get out very much but yeah, I get out a bit more now with the dog and that, and [the HT] said, you know, [the HT] said, ‘Go out walking and try and keep your mind off cigarettes,’ which I did do . . . Yeah, I take the dog out and I do things, you know? Definitely. Yeah, it works, most definitely works, yeah. It’s something there to stop me . . . yeah, to stop me from thinking about it, distraction, yeah.

Female, aged 50–55 years, employed full-time, moderate smoker, intervention, failed quitter

I’m doing my exercises three afternoons a week. And that takes my mind off the smoking. It takes your mind off of smoking actually, the exercise. It really does.

Male, aged 60–65 years, unemployed, moderate smoker, intervention, successful quitter

When [the HT] was trying to put across all the activity side, I found [that when] I was engrossed in doing something, which may have been whatever, I didn’t smoke so much [ . . .]. But then, if I wasn’t doing anything I was smoking.

Male, aged 60–65 years, employed full-time, heavy smoker, intervention, successful quitter

It did become clear that PA was not necessarily the primary way in which people would control their smoking behaviour. It was continually aligned with other ‘distraction’ activities which participants would engage in to manage their smoking behaviour. PA was, for many, just another way to keep busy:

Well I like walking so you know, I’d go out for a walk you know or something like that or, you know, read a book; anything to take your mind off it really, break the routine, ‘cause that’s what smoking is really.

Erm well, keeping myself busy basically, because if I am doing other things I am not smoking so much. I go swimming too you know, but first thing I do when I get up in the morning is have a cigarette you know, so if you can cut that one out you know a good part of the, it is a different sort of day so instead of, you know, having a cup of tea and having a cigarette I would do something for an hour or so.

Male, aged 60–65 years, unemployed, moderate smoker, intervention

Some participants did see more benefit in PA as a way of distracting themselves from smoking than other activities:

It’s more effective because if you’re sat down reading or anything you’ve still got that opportunity to think about a cigarette, whereas when I’m like huffing and puffing along to the aerobics the last thing I want to do is stick a cigarette in my mouth.

Female, aged 25–30 years, employed part-time, moderate smoker, intervention

In one case, the participant had made explicit links between PA and the potential for gaining weight while cutting down their smoking:

I made myself cut down but I haven’t put on any weight, you know, and I think that’s how I explain it [PA], you know, ‘cause some of my friends who have cut down smoking the first thing you hear about is putting on weight, putting on weight, putting on weight, and I haven’t, so I’ve cut down on my cigarettes – well, I have and I haven’t put on any weight whatsoever you know, nothing like that has changed at all.

Male, aged 40–45 years, employed part-time, very heavy smoker, intervention

On the whole, those interviewed found the idea of addressing behaviours simultaneously acceptable, to varying degrees. There were cases where the promotion of PA was not completely appropriate, and people failed to see how the two behaviours linked together. This was particularly the case if the participant already viewed himself or herself as being highly active.

No I didn’t you see, you know [the HT] was telling me about exercises and I mean I do dance and I do swim and I do walk you know this sort of thing, and I am a pretty sort of active person anyway to do an exercise to, ‘cause I think that was one of the sort of objectives of it to up your exercise to lessen your smoking, but with me that didn’t or wouldn’t have worked because if I’d really wanted a cigarette I’d have done my exercise and then had a cigarette, so [coughs] it didn’t stop me from smoking if you know what I mean, to do more exercise.

Female, aged 60–65 years, unemployed, moderate smoker, intervention

For one individual, PA may have reduced their desire for a cigarette while actually doing it, but heightened their desire for a cigarette afterwards:

Int:

I said to [the HT] you know, the truth of the matter is that whenever I actually have a cigarette, whenever I did physical exercise at the end of it I would sort of in some case smoke more [laughs] if that makes sense. It was sort of a reward you know.

TT:

OK, that’s interesting. So for you, you don’t find that sort of doing something active tends to lessen your desire for a cigarette then.

Int:

Well when I’m doing it, but not afterwards, no.

Male, aged 45–50 years, employed full-time, moderate smoker, intervention

Design

Qualitative research was conducted using a basic thematic analysis of individual face-to-face interviews to elicit and describe the HTs’ experiences and views about delivering the intervention.

Sampling frame

An opportunity sample consisting of all three part-time HTs (with a dual role of also collecting data) employed in the study was used to maximise the diversity of opinions in the data. Interviews were conducted both early in the study (1–2 months after starting to deliver the intervention in the pilot trial, to capture experiences of the training course while they were still fresh in the HTs’ memories), and in the last 1–2 months of the 16-month pilot trial (to capture any changes in practice or opinion following extended experience of delivering the intervention).

Measures and procedure

Semi-structured, individual, face-to-face interviews were conducted within a few months of completing the training and at the end of the intervention period using topic guides developed by AT, CGVS and TT, designed to elicit data relating to the aims above. The first interview started with general questions about the HTs’ experiences of delivering the intervention and then asked specific questions about the training course, recruitment processes, intervention delivery (what was working well or badly) and the HTs’ understanding of the different intervention processes. The second interview (at the end of the intervention phase) asked about their ongoing experiences in delivering the intervention and how these might have changed since the initial interview. The interviews were digitally recorded and transcribed verbatim.

Analysis

The data were organised using a basic thematic analysis to provide a simple descriptive-level overview of the HTs’ views. In-depth qualitative analysis procedures were not used here. However, these data will be analysed in more depth alongside the participant interviews and consultation recordings, using framework analysis⁹⁶ to generate an integrated analysis of processes of behaviour change in the EARS intervention. This in-depth analysis will be reported as part of the PhD of one of the researchers (TT).

The training course (see Appendix 5)

Overall, the training was well received and valued in building the necessary skills for delivering both the research and the intervention. The training was an exploratory process to help formulate the intervention, drawing on the individual skills and experiences that the HTs brought to the training; they were all involved in some form of health promotion work in their other part-time employment. The developmental nature of the training gave the HTs an impression that the training process was somewhat disjointed, but equally one HT valued the opportunity to be able to contribute to the intervention development.

When asked ‘what worked well?’ the HTs identified practice sessions (with volunteer clients) and reflecting on recorded consultations, having an intervention manual, and getting formative feedback from a health psychologist as important. There were differences of opinion about how many practice sessions were useful, apparently based on the differences in individual learning styles.

One aspect that the HTs found particularly difficult was the initial assessment of their ‘instincts’ for the intervention (a simulated client interview in session 2 of the training). The intention was to allow the training team to adapt the training to the existing skill levels of the trainees. However, this was perceived to be challenging and disconcerting by the HTs but useful, nonetheless, for the research team.

The several months between the end of training and the start of intervention delivery, due to the logistics of taking occupancy of an office in an NHS facility and delays caused by co-ordinating the recruitment process, was a frustration. However, it was clear that the HTs’ confidence in using the techniques increased greatly with practice and their use of these became more ‘automatic’ as time went on.

Ideas for improvement in the training course included:

• having more content for what to do beyond the initial motivation stage
• having a longer session on motivational interviewing or client-centred approaches and techniques
• practising the protocol for collecting the research data/baseline assessments
• having a short self-reflection period built in at the end of each session
• having the fidelity scale available from the outset to provide a steer on what was expected
• having the trainers model the intended delivery style
• providing a much clearer structure to the training to ‘put the cogs right in the correct order’
• guidance on working with smokers with other substance misuse issues
• including training on how to how to rein people in if they go off track
• reinforcing the idea that a client-centred approach still allows the HT the opportunity, with the participant’s consent, to offer (or exchange) information
• guidance on how to deal with people who are already active
• including more supervision and formative feedback, particularly in the early stages of delivery.

These suggested changes will be very useful in designing the training course for future implementations of the EARS intervention.

Recruitment (see Appendix 5)

The HTs recognised the relative efficiency of recruiting participants through GP and SSS invitation letters after identifying smokers on surgery databases. There were minor initial teething problems in working with surgeries. In contrast, recruiting without an invitation letter from the community was much harder, with many of the strategies used producing few participants. There was a belief that approaching existing group leaders as advocates (rather than directly approaching individuals) could be more promising but that it may take more time to build relationships within the community. The study timeline may therefore have placed constraints on what could be achieved.

When asked ‘What attracted participants to the study?’, the HTs identified a desire to reduce smoking as the primary factor, along with an interest in the research itself and the idea of getting one-to-one support. All the HTs felt that potential participants were ‘not hearing the physical activity side of it’. Reasons reported for non-participation included having other priorities, a lack of time, illness or a lack of interest in reducing smoking.

Making contact with potential participants by telephone was reported to be acceptable, but there were mixed views from different HTs: one felt she was intruding into people’s lives ‘like a salesman’. All HTs reported that this process was time-consuming, as they often needed to make several calls to get hold of the participant.

The most difficult part of the recruitment process was the disappointment expressed by participants who were allocated to the control group. It was noted that increasing the study-completion payment later in the study might have helped with this. No major problems were reported regarding access, non-attendance or workload for participants after they were enrolled.

Suggestions for improvement included:

• offering the intervention to controls at the end of the study to counteract the sense of disappointment (possibly in a group format or as a condensed version)
• developing a strategy for what to say if someone else answers the telephone
• not focusing on PA during the recruitment stage as it ‘sort of confuses people’
• having a more prolonged engagement with workplaces, perhaps via occupational health professionals or existing public health team contacts, which could help recruitment.

Delivering the intervention (see Appendix 5)

The HTs reported no problems in using most of the intended intervention techniques, including exploring a typical day; encouraging self-monitoring (which was seen as particularly useful); problem solving; empathy-building/person-centred counselling; exploring importance (including pros and cons and using 1 to 10 scales); exploring confidence; using motivational interviewing techniques (including affirmation and reflective listening); reviewing progress; assessing existing smoking; offering alternative strategies for smoking reduction; setting realistic/SMART (Specific, Measurable, Attainable, Realistic, Time-referenced) goals (usually verbally, or with the HT writing them down) and making coping plans.

When asked ‘what worked well?’, the HTs identified regular contact, encouraging self-monitoring, MI (client-centred) techniques, pedometers and offering a choice of clear behavioural strategies for smoking reduction.

In terms of delivering the PA aspect of the intervention, the HTs felt that that most people were willing to try to do some PA. However, making the link between PA and smoking reduction was easier for some participants than others. The idea that PA could help to reduce cravings was not generally well understood or accepted. However, the idea that PA could provide a distraction was felt to be more useful/more easily accepted by participants. The HTs also tried to encourage people to do experiments to test the link, with mixed success. Other strategies were sometimes useful (e.g. focusing on the general health benefits, addressing misconceptions about what PA entails). The need for individually tailored strategies was highlighted by all three HTs:

Everybody’s very, very different aren’t they, sort of, receptive to different things.

Tailoring the intervention applied to assessing motivation, identifying and addressing barriers, trying to make the link between PA and smoking reduction and deciding which behavioural strategy (or mix of strategies) to use. One HT reported that making the link to PA was often easier for these participants, although it was not clear why this might be.

For the ‘harder-to-reach’ participants (e.g. those with higher levels of mental health problems or low literacy or analytic skills), flexible tailoring of the intervention seemed to be particularly important although this did not seem to diminish the chances of a successful intervention.

There were mixed views about delivering the process measures alongside intervention sessions (NB: this was also noted as being a potentially difficult process when reviewing the consultation recordings). Some HTs felt that this was not a problem, but others identified a ‘tension between the HT and the researcher role’.

All the HTs felt that the short timescale of the intervention (8 weeks) was a limitation and would have liked to have more flexibility to maintain contact with participants who were starting to make progress.

Encouraging engagement of social support (which was identified by the intervention fidelity analysis as largely lacking) was identified as being potentially problematic/provocative as not everyone had good sources of (positive) support. This was also identified as not being high on the agenda, perhaps reflecting a lack of emphasis on this during the training. Similarly, the issue of identity change was not considered to be a major element of the intervention process.

Overall, the HTs reported feeling very positive about their experiences in being part of the research study and delivering the intervention. They felt that this was a job they would enjoy doing and would apply for it again if it the opportunity arose.

Ideas for improvement included:

• Consider using a solution-focused approach rather than a problem-solving approach.
• Possibly encourage participants to take a longer-term personal appraisal of the benefits of PA, rather than any acute effects.
• Include training on how to avoid or minimise dependence/reliance on the HT.
• Use text reminders as a useful way to remind people about appointments.
• Include training on how to deal with passive resistance (participants who avoid engagement by agreeing/going along with the HT, but then do not make the changes discussed).
• There was a further suggestion that some type of debriefing supervision might be useful, where the HTs could discuss difficult cases or their own feelings about certain difficult clients.
• Finally, there was also a suggestion from one HT that at the baseline interviews, there was a tension between the need to build empathy at this stage and the need not to engage therapeutically. This might result in some contamination of the control group (albeit quite low level).

Early engagement with the intervention

Coming in to the first intervention session, John had completed a week of self-monitoring his smoking behaviour, recording when and how many he smoked. He found this activity to be particularly thought-provoking, highlighting patterns in his smoking behaviour he had not previously considered:

HT:

I don’t know. You obviously do something slightly different at the weekend, isn’t it, because both weekends are exactly the same.

John:

Yeah. Until you brought this sheet out I didn’t realise that.

And with further exploration of perceived challenges for smoking reduction:

HT:

Anything you think you are going to find hard or difficult about trying to reduce?

John:

Well, as I say, it’s those three in the morning and after a meal. That’s basically . . . I’ve got used to sitting at a bar without having a cigarette but no, it’s just the three in the morning with two cups of coffee, and after a meal. They’re the only ones I really enjoy.

The HT gave John a chance to reflect on his smoking behaviour:

HT:

So the other ones, why do you think you have the other ones?

John:

Habit, I think. Just because it’s there . . . except for those three first thing in the morning. The taste gets me. ‘Cor, Jesus, why am I doing this? I’m not enjoying this,’ but I’m still doing it.

After discussion about techniques and approaches to cut down, John adapted his own way to approach cutting down, which did not exactly fit any of the four strategies the HT had identified. He broke his day down into morning, afternoon and evening and began thinking about which cigarettes would be easiest to cut down (hierarchical reduction) and times of the day he would not smoke (smoke-free periods), and talked about extending the time between when he smoked (scheduled reduction).

John:

The evening I could cut out.

HT:

Which ones?

John:

The evening ones, yeah. I could cut them out. But the first three, the first three I’ll have, with my coffee, and then one an hour after that.

John lacked confidence to cut down the first three cigarettes in the morning, and recognised the strong association between his morning coffee and cigarettes. The morning cigarettes would be the last ones John would tackle, and the ones he was least confident about cutting out.

Early discussions about PA revolved around John’s walking habits. He did not smoke when he walked, but he had not made this connection, and there was little engagement in any idea to increase PA at this stage. The HT provided him with a pedometer and he agreed to monitor the step counts. Surprisingly, John raised the possibility of using a gym.

John left the first session with a goal, after the first three cigarettes in the morning, to extend the period between cigarettes to at least an hour and a half and cut out smoking in the evening. He also planned to obtain information about opportunities at the local sports centre.