Qualitative results

Service user perspectives

Our findings suggested that service users had significant experience of overdose (their own or others) and were keen to maximise provision of THN which they perceived as an acceptable and easy-to-use intervention. They valued provision of THN via ambulance (ES) or ED staff in addition to community provision. Although they expressed concerns about risks of wanting to leave the ED or ambulance quickly after reversal, due to potential side effects of rapid withdrawal associated with naloxone, they valued its life-saving benefits. Service users spoke about THN training and provision giving them a sense of self-agency and empowerment and users perceived this as an opportunity to save lives. Users also felt there were opportunities for friends and family to also undergo training and receive the THN kits.

Theme 1: service users had wide experience of overdose and high level of knowledge of how to manage overdose, with or without THN

Almost a third of the interviewees in the study had experienced an overdose themselves and nearly all had observed others overdosing at some point. In discussing their own overdoses, participants described a range of different experiences, with or without naloxone or THN. One participant described being found by her mum:

I was at my mum’s and luckily my mum knew what was happening ‘cause my mum knew about what I was doing at the time and I was sort of not responsive…I was sort of quite ashamed of myself ‘cause it was – at that time it was an accidental overdose.

Another participant was revived in the street by someone carrying THN:

I was lucky, yeah. It wasn’t actually on these premises [treatment centre] but it wasn’t far away. And there was a member of staff who had naloxone in her bag and she brought me round.

Participants demonstrated a high level of knowledge of how to respond to others in an overdose situation and described either observing or trying to help others who had overdosed. Participants discussed calling the ambulance, using CPR, getting the patient conscious and moving, or putting them in the recovery position:

So I’ve gone up to him with another lad that I know and we picked him up and basically forced him to walk around the park. Which I – we thought was right.

Called the ambulance. Put them into recovery. At that time though, there wasn’t Naloxone pens about. So, yeah, so I just called an ambulance.

Some participants also described administering THN if someone had a kit on them:

I was on the stairwell … and I had my Naloxone with me and my friend went over and I phoned the ambulance. They asked me if I had one [THN kit] with me. I said I did and they told me to use it and I did.

But basically they say one dose is one, but what we did to a friend was we give him two and then when that weren’t really doing owt we give him the rest.

Generally there was a high level of knowledge overall about the existence of an overdose reversal drug, with only one participant stating they were unaware of a reversal drug being available. All were aware the drug worked instantly. Participants described having received naloxone from paramedics, but some had also been given THN by a peer drug user:

I’ve been using drugs since I was fourteen. I’ve gone over twice in that time … my friend gave me it the first time and brought me round. And I was quite ill after, and angry. But it brought me around. And the second time it was from the ambulance people.

Some participants believed that ambulance crews used different, stronger drugs than THN, commenting ‘the Naloxone that paramedics carry is different to the Naloxone that you give us’ (Site 1 ED 02) with one participant stating that he had been given ‘Ketamine’ (Site 2 ED 10) and another ‘Adrenaline’ (Site 1 ED 04).

Users valued naloxone and THN as a life-saving drug and acknowledged the paradox of the ambivalence of how it felt to be treated at the time, recognising that the immediate behaviour did not demonstrate gratitude. However, users appeared to strongly value the opportunity to have access to the life-saving drug, and valued their own lives and that of other drug users:

You know, you’re quite selfish, they’ve saved your life and then you throw it in their faces.

Theme 2: THN was perceived to be an easy-to-use, simple and effective intervention that users would be willing to carry and use and increased their sense of self-agency

Interviewees valued the opportunity to have access to a THN kit, with participants who had experienced THN being used by other peer users being particularly positive about the benefits of THN and feeling encouraged to carry a kit themselves:

If I knew somebody’s life were at risk I would 100 percent use that without any shadow of a doubt.

So my experience of Take-Home Naloxone, it’s dead handy, especially for if someone goes over, and I’ve actually witnessed it and used it, so yeah, it’s good stuff.

An associate come round into the flat … overdosed and everybody’s head fell off, but this was given to him. Now when this was given to him he was coming onto his hands and knees as the ambulance was coming through the door, so I seen it actually work you see, so then that’s what made me ask for this (THN kit).

Several interviewees felt that being trained and given resources to help themselves and others and given them a sense of agency and empowerment:

I felt a bit big-headed actually … Cos I had the kit and I knew what to do with it … I felt quite privileged for them to say that this is not just for you, this is for – you know what I mean? ‘Cos it gives me a bit more responsibility … it makes me want to be around people, like if I need to inject or what not, instead of just going home and being on my own with the dog, I’ll make sure I’m with somebody now. Now I’ve been able to educate people myself.

Some participants had received THN training in the past, with some carrying kits themselves or had a family member who was trained to use a kit. Those who had received the short training expressed confidence in being able to administer THN if necessary:

If I had to find a vein or owt’ like that I wouldn’t be confident enough, but the fact that it goes straight in a muscle and it can go through clothes, it’s just, it’s really simple.

Interviewees were positive about the size of the THN kit with many commenting on the clear, easy-to follow instructions as well as the small size which meant it could be carried in a pocket, handbag or rucksack easily:

I wouldn’t mind having it in my backpack and keeping it in there.

No, it’s a perfect size, it’s perfect.

Many participants supported access for family, friends and partners as well as peers who may be users themselves. When discussing the training and how to use the kit, some felt that it might be difficult for family and friends to administer the THN but overall most were positive about this option:

I mean most people have got a family member who’s worried about them, might have a mum who’s worried about them, a sister or something like that. So obviously they might want to get some training and have this little pack just in case, you know.

I think it’s a good thing. I think people should be encouraged to have one, certainly if they’re in a house where other people come to use there.

Theme 3: participants expressed mixed views around the risk of using naloxone, in terms of a recipient being aggressive on revival, and around calling the emergency services

Participants expressed some concerns about calling for help for overdoses due to the additional involvement of the police, with fears around arrest for possession and supply of drugs. Longer-term drug users recounted more negative police experiences and fear of arrest etc., but this was usually when they recollected overdose experiences from some time ago:

The thing is there’s a fear round drug users that if you start ringing 999, the police are going to come, but a life’s a life, isn’t it?

I didn’t dare hang around and do it. Because, like I say, I had loads of drugs in my pocket.

Overall, there was general agreement that police were now concerned with safety rather than any issues around taking an illegal drug:

Well, we’d heard that in the past, that people were abandoning people and we’d heard that they’d changed the way they dealt with the people helping somebody because of that very reason, because they were getting abandoned. So we kind of were led to believe that we wouldn’t be held to any accountability for helping him.

I would still, you know, phone them up and say, look, you know, ambulance, he’s overdosed, he’s had whatever, you know, explain everything onto the phone. Whether the police come or not, I know I’m not getting arrested.

Due to the potential of the naloxone drug wearing off faster than the opioid effects, and the risk of a person who has overdosed going back into respiratory depression, it is important to phone ES and stay with the person, to administer another dose of Naloxone if necessary. However, some interviewees did recount experiences when resuscitation using THN was carried out without calling ES:

Cos, you know, if you’ve got Naloxone and someone’s gone over and you put Naloxone in them and they come back round why do you need to waste time phoning an ambulance?

I kind of felt – with the Naloxone there, I kind of felt in control. If she’d – if I’d given her the Naloxone and it hadn’t brought her round, the first thing I’d have done was ring an ambulance.

A predominant theme among those interviewed who had experienced an overdose and then been given naloxone, was feelings of anger and confusion at the first instance. Almost all respondents recounted the physical side of very quickly losing the ‘buzz’ of the opioids’ effect, resulting in going into rapid ‘withdrawal’. This was described as frequently causing headaches, paranoia and confusion and also provoked feelings of anger:

Yeah, I’m just like where has my buzz gone, what the **** have you done like, do you know what I mean, where’s my drugs? I thought he’d robbed me, I woke up and I had no like no recollection of what was going on, I was just like what’s going on, where’s my drugs, why ain’t I buzzing, do you know what I mean?

And I was furious, I wouldn’t go in the ambulance. I was like, no, they’re going to take my drug, you know, they’re going to give me Naltrexone or something, no.

This was also viewed by some, in terms of caution in administering the naloxone to others, particularly if it was felt that the person might become combative or angry:

My friend was a bit pissed off and that’s because he had no opiates in his system and straight away he wanted to use drugs.

However, even though there was acknowledgement of how someone might behave after they have been given the naloxone, almost all of the interviewees felt they would still give THN:

I’d be more hesitant but at the end of the day like I’d still, you know, I’d value the person’s life more than getting a bit of grief over them coming out of their high.

I think I’d still – knowing that, still use it because I think it’s still more important to have someone confront you than potentially lose a life, so yeah, I’d still administer it knowing that.

There is some evidence that taking another dose after receiving naloxone to reverse an overdose carries a higher risk of overdosing again and this has been outlined as a concern around THN in the literature. Some participants felt this would be the case:

I didn’t realise there was a twenty minute period where you’ll start – you withdraw for twenty minutes and then you don’t, so I was just really pissed off with that, I thought I’d lost my hit. Then ran round trying to get more money [for more drugs].

Yeah but I mean, the first thing they want to do is go and get some more drugs. That’s the problem really, rattling is not comfortable at all.

Linked to this, participants’ opinions were very mixed concerning whether or not having access to THN would lead to opioid users taking more risks, knowing that a safety net was available. A few participants believed that others might be encouraged to take higher amounts of opioids:

If I’m with someone taking drugs and I knew that person had Naloxone would I take more to overdose? Probably, yeah.

If there’s a safety net there, I think someone will be greedy as well. So, that could make it worser.

Even though some interviewees acknowledged that this may be a potential risk, overall, the consensus was that quantities of drugs taken were more influenced by factors such as amount of money available or type of drugs available, with some commenting that they would take as much as they could afford and were not in a position to increase this at will:

You can only take what you can afford at the end of the day.

No, they don’t, they take what the money can buy, it’s not about well I’ve got this much, do you know what I mean?

Importantly, it was commonly stated that the risk of overdose was something to be avoided at all costs, and therefore it was unlikely that people would take more drugs and knowing it could increase overdose risk:

...if it was me personally I don’t think I would, … cause I wouldn’t want to ever be in that position of overdosing again anyway.

Nobody wants to go over, nobody wants to go over because it’s big rigmarole. You don’t know what’s going to happen, you don’t know whether you’re going to be here or not. And it’s scary, it’s a scary thing.

Theme 4: opioid users supported much wider provision of THN

There was a common consensus that THN should be widely available, with almost all of the participants citing chemists, needle exchanges and places like drug treatment services as places where THN kits could be given out. Participants felt that chemists in particular, where some obtained methadone and therefore visited on a daily basis, would be a good place to get the THN kits and training:

Oh, doctors, pharmacies that give out pills. Like, places that do needle exchange should be offering Naloxone. If they’re giving out bags of pins, they should give out Naloxone, I think.

I think the chemist ‘cos where are they going to get their pins from?

All participants in the study were asked specifically about their opinion on THN kits and training being given out by both paramedics on scene and also in hospital ED settings. Although overall, interviewees were positive about widening access to THN training, there was less clarity when considering the hospital ED and ES THN provision specifically. A common experience was being treated on scene for an overdose but not going in the ambulance to hospital. Many explained this was due to the instant withdrawal caused by reversing the opioids:

If they’ve got it on the mind to get drugs. Drugs is all important to them and if it’s the case that they don’t hang about, it’s the rattling.

Almost all the participants commented on either not wanting to go into hospital themselves or observing others refusing to be admitted to hospital by the ambulance staff. This was generally felt to be due to the experience of rapid withdrawal outlined. One participant, however, did feel coping with withdrawal symptoms was a reason for being in the ED, while at the same time expressing concerns about this leading to being more at risk of an overdose by taking more opioids straight away:

If you’ve got it IVd it will clear all the opiates out of you instantly and you’ll be clucking and then you want more. And the risk is because you’ve got Naloxone you’re not going to feel it, so you’re going to go over again. So, it’s best to take it with the hospital if they have a decent place for Naloxone, because they’re going to try and use to get rid of the withdrawal symptoms. And they won’t feel it and then they’ll use more, you know. It’s a catch-22 situation. It’s quite a bad one. You can’t get rid of that feeling. You’ve just got to ride it. Yeah.

Although interviewees were ambivalent about provision in the ED, possibly due to less experience of being treated for overdose in the ED setting, there was more support expressed for THN provision by ES staff attending overdose calls. Participants felt there would be an opportunity for ambulance staff to give out kits and training at this point:

Both the people that overdosed in my eyes didn’t go in the ambulance. Because they probably wanted to go get more drugs they didn’t go in the ambulance. People just don’t like to go in the ambulance … it maybe would be ideal to give the five, ten minute training or whatever it is, show them, leave them one.

They come round and they want to go home. They normally will see an ambulance staff … even if they don’t get in the ambulance.

Treatment on-scene and being given THN training at that point was also viewed as more effective by some participants:

Anything that will cut down on A&E waiting times is a good idea in my book.

Interviewees felt that there were opportunities for ambulance staff to give out THN kits to peers and family/friends or bystanders while attending overdoses. Not as much support specifically for THN training in the ED setting was expressed, but many included ED provision more generally in widening access to THN:

The more they get out and the more they get it to circulate, the sooner the better, as far as I’m concerned.

Summary

Few studies have examined THN provision in the ED and ES, particularly from the perspectives of those who have direct knowledge and experience of opioid overdose and treatment. Participants in the qualitative interviews, attending an outpatient treatment clinic or drug support organisation, had a high level of THN knowledge and were highly supportive of widening of THN kit provision. Current and previous access to kits varied across those interviewed depending on different community, third-sector, and NHS support service provision. Many participants felt that THN should be given out in a variety of settings including chemists and needle exchanges as well as in the ED and ES settings. Participants acknowledged that there was resistance to attending hospital in an overdose situation and this therefore may have increased ambivalence about THN provision in this specific setting. Training from paramedics was generally considered a good idea, but some acknowledged the drawbacks, the main one being people going into withdrawal and wanting to immediately either go home or re-use.

It is important to note that universally in our study, overdosing from opioid use was viewed as an accidental event to be avoided and ameliorated as much as possible. Participants were highly motivated to both help others in that situation and to avoid it for themselves. THN provision increased self-agency and empowerment in service users. Inclusion of friends and family in being trained to use a THN kit was important to many in the study. This was viewed in the wider context of support for increasing access to THN.

Service provider perspectives

In total we conducted 14 interviews (8 paramedics, 4 ED staff) plus one focus group with 8 ED staff (see Table 16 for details of characteristics of participants).

Findings

We present the findings broadly in relation to the NPT constructs, then discuss issues relating to the trial and recruitment to the study. The first two constructs describe how staff perceived the purpose of the intervention, specifically how it works (coherence) and who has a role in implementing it (cognitive participation). Issues relating to the implementation of the trial itself (rather than the intervention) are discussed mainly within the latter two constructs (collective action and reflexive monitoring). Within collective action we anticipated exploring the question ‘how does the work get done’, focussing on the compatibility of the intervention with current work, training and resources required to enable the provision of THN. However, due to low uptake of the trial, we focus instead on recruitment and implementation of the trial itself. Within reflexive monitoring, we considered whether the intervention was perceived as advantageous, whether the effects of the intervention were clear and whether it could be adapted or improved.64

Normalisation process theory 1 – Coherence (what does the intervention involve and what is its purpose?)

• Participants demonstrated high levels of coherence in terms of understanding the aim and purpose of the intervention.
• Some scepticism around benefits of TNH when given in emergency situations due to patients not wishing to engage.
• Recognised benefits of THN as distinct from naloxone itself in terms of providing opportunities for education and empowering patients and their families.

Overall, both ED staff and paramedics recognised the value of the intervention and had a clear understanding of the aims of the trial and how it related to their work practice. Participants demonstrated a high level of coherence in describing the purpose and potential benefits of the intervention: reduced mortality and morbidity, as well as wider benefits to the health service in terms of reduced attendance at ED and/or ambulance journeys for future overdose. Participants recognised naloxone as key to reducing fatalities and morbidity for opioid users, with many having witnessed opioid reversal themselves:

I think from an intervention, I mean, I hope the benefit is that it reduces mortality and morbidity for those patients. They’re a very high-risk group of patients. The local addiction service here are pretty good and have been giving out Take-Home naloxone for probably quite a long time, and I’ve been to numerous patients who had Take-Home naloxone administered to them. I mean, you don’t know what would have happened to them but in my eyes, when you get there they’re alert and they’re a good colour, and there’s been some clinical benefit for that for me.

The reduction of fatal overdoses, to us, makes it worthwhile straight away.

Overall it would benefit all round because it would prevent admissions to A&E so I think it would be cost effective, and it’s a relatively simple thing to take on board and to cascade down to patients.

In addition to the benefits of naloxone, participants also recognised potential additional benefits from the interactions associated with providing THN and the opportunity to encourage opioid users to engage in further treatment. This interaction was viewed as a mechanism for enabling ED and paramedic staff to spend time taking part in education and health promotion conversations and engage with a hard-to-reach population who may otherwise not have much contact with health services:

I think it’s obviously to reduce avoidable death through opiate abuse. I think it enables practitioners to have health promotion conversations with people in that lifestyle. And really to some extent it’s a kind of ‘make every conversation – make every contact count’ message but the patient goes away with something useful at the end of it.

Like I said, I mean, we all know that people shouldn’t be taking opiates and things like that, but they will. And if we can get it so we’re – we can stop some preventable deaths, a lot of people die from taking drugs. If we can help support them to stop them dying, and even if it gives them an education enough to get off the drugs in the end, you know, we can make it a little bit safer for them and give them that opportunity to actually get through it.

Delivering the intervention via ES was seen as an opportunity to widen access to THN for a specific, high-risk population, and participants felt that they were in a unique position to be able to connect with opioid users who were not accessing services elsewhere. Some staff saw also implementation of the intervention as a way to relieve the pressure on other drug support services and increase levels of collaboration generally across support services:

think we catch a lot of things. Like I was saying, we are privileged to be accepted into these places that people wouldn’t normally see. So we can catch those people who maybe – they wouldn’t go to the GP for help. They might not engage with services, they might not even know they exist. Whereas we’re called at the crisis point, people panic, they call us. So we’ve got that chance to actually engage with them.

I guess just to maybe catch a population that aren’t accessing – these people live very chaotic lifestyles so they’re not all accessing addiction services and GPs and things like that. I guess just to potentially access a group that may not be accessing conventional services.

Participants suggested that ES provision of THN with education and training had potential to increase self-efficacy and empower both opioid users and their peer and support groups. It also gave providers a sense of being able to help a population for whom they felt they could offer little support:

So, that’s what I saw as the key bonus to this scheme, was that it wasn’t just about supporting and educating people and saying, you know, “Recognise this risk and call help”, but also being able to say, “This is something you can do”, and kind of like empowering them at the point of care.

I guess, friends and carers and relatives, as in, they might feel more powerful to help in that situation or have something to do.

It is a nice thing to leave people with, it sort of shows that we care. It’s another thing we can say in good faith, we saw this person, we discharged them after a heroin abuse episode that went a bit awry and we have left them with a life saving drug. And I think that’s a nice thing to do to people.

Normalisation process theory 2 – Cognitive participation – who has a role in delivering the intervention?

• Participants within this study saw provision of THN as compatible with their role and that of their organisation.
• Low engagement with the trial suggests that buy-in may be lower from other colleagues. Differing views may then feed into reduction in collective action.
• Evidence of work being undertaken to increase engagement.

Interviewees saw the provision of THN as broadly compatible with their roles and the role of their organisation. ED staff were used to dealing with opioid users in their day-to-day work and the intervention was not felt to represent a significant change from their normal work practices. Nursing staff were involved in identifying patients for recruitment, with the prescribing of THN and training undertaken either by medical staff, or nursing staff with PGDs. The training and additional conversations required with opioid users were integrated into existing discharge procedures and acknowledged to take some additional time, particularly when the patient was less able to engage following overdose reversal:

So the only difference is just before the patient was discharged you would just ask them if they wanted a Take-Home Naloxone, or if they’d heard of it, and if they were interested in having one. So that would be the only change. It’s just before discharge we would ask them if they wanted a Take-Home Naloxone kit.

From a point of caring for the patient, I don’t think there is a lot of difference really. It’s more than just offering them the chance to take the kit home. I guess that involves a bit more time and education, because we wouldn’t necessarily routinely go through all the recovery position and talking through effects of overdose and things before.

Paramedics within this sample described the THN intervention as compatible with their job roles and perceived the provision of THN as an opportunity to be proactive and engaged in public health and preventive medicine. They welcomed expanding their scope of practice and recognised this as an opportunity to increase the value of their interaction with opioid users, compatible with the ‘make every contact count’ approach being advocated by the ASs:

As a paramedic I’d say yeah it’s very compatible ‘cos the frontline ambulance paramedics are going to those patients on a more regular basis than we [specialist role] are. I know from previous experience, certain hotspots within the [name] area that when an address pops up on the screen on the computer you know instantly what the job’s going to be, nine times out of ten. So it would be good to know with the regular callers and the regular addresses, that it’s a high likelihood it will be an opiate related incident and to have the kit there ready to take in with you.

I think it enables practitioners to have health promotion conversations with people in that lifestyle. And really to some extent it’s a kind of make every conversation – make every contact count message but the patient goes away with something useful at the end of it.

Participants described frequent interactions with opioid users within their day-to-day work and saw THN as an opportunity to provide an additional service not only to opioid users but also the friends and family, particularly when attending the home setting. They felt that having the ‘captive audience’ in the ambulance put them at a potential advantage over the ED, where staff may struggle more to engage opioid users after their overdose:

But in terms of us paramedics, I think we’re ideally suited for it being a pre-hospital medicine. It’s quite different to in-hospital medicine and I think we get, you know, a different take on what kind of these people – what happens to these people, you know, in the initial stages of an overdose anyway. And certainly, in the pre-hospital interventions that we do, often they don’t go to hospital because like I say, often they just walk off or tell us to leave. So, I think we’re ideally placed really, to try and – at least try our best to try and get people to engage with this.

Yeah, I think it’s an extra tool I can use. It has its place, and I feel like it’s that kind of thing where because historically we were kind of reactive, using this we could be more proactive as well. So personally myself I think it’s a win/win situation.

I would say that a lot of times we would go to overdoses, that would then refuse to come in because you’d give them the NARCAN and they’d wake up, and have capacity to refuse. So it would, potentially, be good because you’re also in the environment of the house that they live in, with other people there in their actual environment. So I feel like I probably would have had more opportunities.

There was evidence of commitment from staff in helping patients to access the THN and managing the anxiety of patients who were coming out of overdose. Although interviewees primarily identified potential trial participants as opioid users who were experiencing overdose, THN had also been given pre-emptively for known opioid users who were attending for other reasons, at a point when they would potentially be more amenable to receiving the kit:

So I think I issued one for someone who had a groin abscess due to injecting, I knew was a heroin addict and just sort of said, “What do you think about this?” He was like, “Yeah, that’s probably a good idea, isn’t it?” So we signed him up.

SP11

Or sometimes we’d recruit them if they were active drug users, but they’d come in for another problem. A lot of the time we see people who come in with health problems relating to their drug use, but they haven’t actually overdosed, but they are at risk of overdose. So those people, ‘cos they’re here for a different reason, we would offer it to them.

Even people who’ve been quite difficult in A&E when I distributed it to someone, he was quite an aggressive patient. Yeah, post NARCAN treatment, they can be quite aggressive from it. But, once we sat down and talked him through it, he was actually sort of very switched on, compliant. I’ve given it the once, so my – I mean, my experience was good from it.

Although recognising their role in widening access to THN, staff spoke of the inherent limitations to providing it through the ESs. They expressed reservations about the willingness and ability of this group of patients to engage with the THN training during their episode of emergency care due to reduced capacity to retain information, concerns about obtaining further drugs and desire to return home as soon as possible:

From my point of view, I think … it’s not been very successful, because of the reasons that I said about the engagement and the fact that we often struggle. Well, I admit that we often struggle to convince people to take it, to take the training or to even take the – what we’re offering them, in terms of the take-home naloxone. Often because they just don’t want to engage … and the other reason that just we’ve sort of spoilt their hit, which is awful, when you say it like that, it’s awful, I’m sort of in two minds about that, but yeah, I think that’s the number one thing I’ve found anyway.

So, I think, obviously, the people that generally present to ED having overdosed, will be drowsy, you know, take a while to recover, which obviously means that they’re not going to be able to take information in well, or engage. And, as I’ve said before, at the point that they then become more awake, then they don’t always want to stay to engage. So, that would be a barrier, I think.

While participants within this study expressed support for THN provision, their ability and willingness to drive it forward may be hindered by limited engagement from other staff. Sign-up for the trial had been limited and participants indicated that the beliefs and behaviours required to enable widespread acceptance of the intervention may not held by wider colleagues, with some evidence of wider scepticism about the provision of THN by ESs. Concerns arose from apprehension about the ability to make a significant difference at a population level and about the ‘safety net’ effect, whereby opioid users take a higher dose because they know the drug reversal drug is on hand if they do overdose:

I don’t personally agree with them, but other paramedics on station I spoke to were like, ‘Why on earth are we doing this? This isn’t something we should be doing. We’re just giving them kits and we’re essentially encouraging them to overdose again.’ Again, I disagree with that strongly, but I would say it’s split opinion a bit.

When we discussed it within our team, so over a cup of tea, I think there was a variation in enthusiasm for it. Some people wondering how effective it would be, feeling that it was difficult to target the people who would be most vulnerable. […] Some people felt it was, you know, a thimble full effect in a bucket full of problem.

Some patients are their own worst enemy, so they might have some controversial view of them. Just thinking “well, people who take drugs are a waste of space” and all this kind of stuff. They are getting fewer and fewer, but there is still this – because of the patient exposure that we get and the demand that we get, the amount of jobs that we’re going to on an hourly or daily basis, it is phenomenal[…], sometimes I think people’s empathy buckets have run out.

Normalisation process theory 3 – Collective action (how has it been delivered and what has enabled or hindered uptake?)

• The trial was felt to be well resourced but high staff turnover impacted on numbers of staff recruiting patients in some sites.
• Recruitment of patients to the trial was lower than expected due to lower-than-expected numbers of eligible patients (with many in the prehospital setting having persistent low consciousness levels, and others having already received a kit), low engagement from patients and changes in protocol.
• Changes to protocol midway through the trial led to confusion about who was eligible, and when the trial was recruiting.
• Opioid users were not always receptive and there were high numbers of refusals in the ED setting.
• Recruitment of clinicians was low at some sites, particularly EDs, due to other competing trials, COVID-19 exhaustion and lack of conviction.

Staff generally felt that the trial intervention was well resourced, and was a positive, experience in particular with regards to the delivery and content of the training, but they struggled with recruitment of both other clinicians to train and opioid users to enrol in the trial. There was evidence of work undertaken by research leads to encourage and facilitate recruitment to the trial, particularly at the ED where there was a specific research manager who ‘championed’ the project:

She’s done very well, you know. The forms are very easy to find, you know, the – where the medication’s kept, it’s really easy to find. You know, there’s signs up.

It all got cascaded down quite well for us from [Research Lead Name]. She was very helpful, and she was always on the end of an email. If we had any query or question, she would reply within a few hours, so that part was really good.

However, high staff turnover in both the AS and ED resulted in difficulties in recruiting and training sufficient staff for the trial to be adequately cascaded and maintained. Competing trials taking place at the same time was also felt to be an issue for recruitment and retention, as was the administrative burden of trial procedures (logging patients, Site 2 ASF paramedics signing the THN kit in and out for every shift) for paramedics in particular. This was particularly problematic in the context of the COVID-19 pandemic due to increased movement of staff to different locations and roles, and increased time and energy expended on dealing with the pandemic:

The difficulty was the trial had been running for quite a long time and the department has a really high turnover of staff. So I would train people and then they would leave, or there will be people that haven’t been trained in it that because they’re just coming through constantly, I couldn’t keep up. Also, even if they did have the training the trial’s been running over a period of two years so they might forget everything I’ve said or some of the things I’ve said.

We also had quite a lot of other trials going on at the same time. So, I think you need to – if you’ve got lots of people involved in trials, sometimes they just tend to concentrate on one. Whereas we had quite a lot of trials going on at the same time as this one.

Um, I think it was a bit – I understand this is study design, I do understand, but having the additional administrative burden of having to sign it out and take it everyday, and then remember to put it back at the end of the shift, to sign it in and out was probably a bit, what’s the word? A bit, er, a bit of a detractor from people’s passion for doing it.

Recruitment of patients to the trial was reported to be affected by limited numbers of eligible patients, high numbers of patient refusal and confusion around the trial design. Recruitment pauses due to protocol variations and the COVID-19 pandemic meant that staff were not always aware when recruitment was open and may have missed recruiting suitable patients when recruitment had re-opened without their knowledge. Participants reported a reduction in numbers of people using opioids on the streets and lower numbers of overdoses during the COVID-19 pandemic, with paramedics particularly noting a reduction in the number of potentially eligible patients that they saw:

Also, I think another barrier is having something like a global pandemic because everyone’s focus is on that and so we’re probably not treating other stuff as well as we normally would when we’ve got that focus. Although, to be honest, we are still functioning as a normal department, so we treat all manner of problems. It’s just having that focus makes it a bit difficult because it’s a distraction, and it changes a lot of our practices, and causes a lot of upheaval.

I think so. I think it can be difficult from a medical staff point of view, because in A&E we have a fairly high turnover. So, a lot of SHOs are only in the department for four months. And I think there was a big push with the trial and, you know, putting up the posters and really trying to make people aware. But with COVID and obviously other things that have gone on, I don’t know that the message has been as clear or consistent throughout the whole time.

Because we struggled initially, before coronavirus, and obviously when coronavirus came along with the first wave we stepped back because there was no way anybody was going to sort of have time or energy or anything to do. And I think the trial itself was paused as well.

In addition, management protocols for opioid overdose limited the number of potential candidates to the trial, as they recommend that ambulance crews tried to keep patients from fully coming out of overdose so they were safe but not fully alert. This precluded recruitment to the trial as patients with a low Glasgow Coma Score could not consent to participation in the trial:

So, I know when I went through my paramedic training, there was a big emphasis on if the, you know, respiratory rate is good and the observations are good, just keep them in that groggy state until we can get to somewhere that’s more – that’s safer. Be that a hospital or wherever it might be. But yeah, it’s – I think a majority of colleagues that I’ve worked with have found the same problem.

Similarly, the increase in THN kits from elsewhere impacted on trial recruitment as patients with a THN kit either did not wish to be enrolled in the trial, or were ineligible to be recruited. THN kits had been obtained from drug services, peers or from the trial on a previous occasion. One paramedic stated that drug services had ‘already saturated the market’ (SP2 ES), and the community drugs team were identified to be handing out THN within one ED which temporarily prevented staff from recruiting ED patients to the trial:

They’ve already got sort of naloxone given to them by drug and alcohol services and they’re quite happy to just be on their way. Yeah, so I’d say maybe one colleague, I think I’ve heard of who has managed to be successful so far. Which isn’t a lot.

I never actually managed to give any out. So, either they’ve already had it, because obviously, the [City] Drugs Project also give it out. The [ED] were also giving it out as well.

Staff reported finding many patients difficult to engage, either due to side effects of naloxone treatment or because they were unreceptive to the idea of THN, and not understanding their own risks. Additional time and commitment from staff were necessary due to the difficulties in recruiting and training patients when coming out of overdose, particularly when ensuring that instructions for use of THN were understood. This could be particularly challenging if patients were drowsy, confused or combative, as was the case when they were recruited post overdose and suffering with the side effects of naloxone treatment:

And often, if we give them such you know, a rapid reversal of the opiate, some of them can become quite aggressive, because they come around, they don’t know what’s happened. They’re confused, they’re hypoxic, you know, they can become quite aggressive, and there’s not much room to work in the back of an ambulance sometimes.

Well, it is an extra thing because you’ve got to go through the whole, what you do when you find an unconscious patient and CPR and all that kind of thing. Which can be quite time consuming, to get the person to understand and demonstrate that they understand.

Well, most of the time you have to talk them into it I would say. Most of the time they’re like, ‘No, I’ve got one already, I don’t want one. I’ve had one’. Or they’re just not interested at all, or they’re in denial because they’ll say, ‘Well no, ‘cos I don’t..’., even if they’ve attended the department with a life-threatening opiate overdose as a result of their use, they’ll say, ‘Well no, ‘cos I don’t use very much and I’m not at risk’.

Normalisation process theory 4 – Reflexive monitoring (how do participants reflect on or appraise the intervention?)

• Staff struggled to assess the benefits of the intervention within emergency settings, partly due to contamination (THN kits from other sources).
• Participants supported the use of the intervention but wished to see it adopted as standard practice in emergency settings, not as part of a wider trial.
• Participants supported enabling staff in other roles to train and distribute THN, and also make the kits available to friends and family.

We asked participants how they perceived the success of the intervention. Overall, there appeared to have been little evaluation of the intervention in terms of formalised evaluation or audit, but support for continuation of the intervention outside of a trial.

Participants expressed concerns about how they could evaluate the benefits of the TIME trial itself (rather than just whether the trial was feasible) due to the proliferation of THN kits provided by other settings within the intervention areas (e.g. community providers or even drug services elsewhere within the Trusts). This not only influenced recruitment to the trial but made it difficult to understand whether changes in outcomes were due to the TIME trial or other initiatives. Due to the difficulties in engaging patients in the ambulance or ED when coming out of overdose, there was some scepticism about provision in the emergency settings being as valuable as other settings where staff were better able to engage patients:

So my experience in [City] is I’d say – I understand the – I think there’s saturation – not saturation but I think that drug services have got a longer term relationship with people, have done very well. I don’t know, and having said I don’t know I’m not saying this in a cynical way, I don’t know how much of an impact us carrying give away Naloxone has been for patients, if you see what I’m saying.

So I think the main barrier is the patients [laughs], because with the drugs project I think they find it easy to give out these kits because the patients are choosing to engage with them already. Whereas in the department, they have attended for another reason or they’ve attended because they’ve taken an overdose, but they’re here accidentally if you see what I mean. So a lot of the time they’re actually not interested in taking it because they’re not here for that.

However, participants understood the benefits of THN from seeing naloxone being used successfully outside of the TIME trial, and did not appear to be awaiting the results of the trial to understand the benefits of the intervention. Overall, both ED and paramedic staff perceived ES THN provision to be a low-cost, low-risk intervention that could and should be incorporated into standard work practices. Participants strongly supported the incorporation of the intervention into normal practice and rolling out to other EDs and ASs, outside the confines of a trial, which would address problems associated with consenting patients into the trial. Participants suggested ways of incorporating the intervention into usual practice, including incorporating distribution of THN into the induction and training process and ensuring THN was part of the usual ambulance kit:

I suppose it’s just mindsets, basically. Because a lot of the things that come in, say, thromboprophylaxis for people who can’t have a weight-bearing cast. That was brought in, this is now the policy, this is the checklist. And then it’s just gradually instilled in people. So just part of the process. So I suppose it’s just around that, isn’t it, really, just getting it into people’s mindsets that if you see somebody who’s had an opiate overdose, that is just part of their patient journey, it’s supposed to be part of their assessment and treatment, two parts.

Yeah, I mean, I would like it to be rolled out as a standard operating procedure, as a care pathway that is available to all staff in [the ambulance service]. And you know, every ambulance carries a drug box with naloxone. And I would like us to be able and empowered to hand that out in an appropriate way, as part of a standard operating procedure.

Suggestions about how to improve distribution included use of champions to explain the study, and broadening out the provision of THN to other people (friends and family) and by other roles (e.g. ambulance technicians). Staff felt that the intervention may be more effective if staff in different clinical roles were eligible to take part in the training and the distribution of the kit and if the intervention was made available to friends and family:

It’s being restricted to registered healthcare professionals, whereas naloxone can be administered by a much wider range of people. You don’t need to be a registered healthcare professional to administer it. But I understand why registered healthcare professionals have been recruited to the trial as the practitioners, but don’t necessarily see that as being a barrier to who could be involved in kind of take-home naloxone kind of distribution.

It’s difficult, it’s a fact, yeah, at the moment, because it needs to be signed out as a controlled drug, it’s mainly for the patient. Whereas, actually, sometimes it would be better if it wasn’t just the patient, if we could have the ability to give other people who are with them the kits as well.

Reflections on recruitment of staff to the qualitative interviews

Within our later interviews we asked why we had struggled to recruit stakeholders to undertake interviews. Paramedics described the impact of the COVID-19 pandemic where staff were prioritising urgent COVID-19 related work and had less time and energy available for non-urgent work. Participants related reasons mainly around poor communications, which were principally done via e-mail, with people being unaware of the thank-you payment offered or that we wanted to talk to anyone who had undertaken the training and not just those who had handed out kits:

We’re talking about staff groups who are traumatised and exhausted after a year of a lot going on. Um, and perhaps it’s just not been the optimal time to try and recruit people.

Summary

Overall, participants were positive about the intervention and perceived the intervention to be compatible with their roles. There was surprisingly limited discussion of potential risks associated with the intervention, with participants focussing principally on potential benefits, albeit with an acknowledgement that benefits may be limited to a subset of the intended population. Although there was some additional work associated with delivering the intervention, there was evidence of work being undertaken to improve provision of THN and to try to recruit patients. Recruitment into the trial was problematic for a number of reasons, including the COVID-19 pandemic, and staff supporting the idea of incorporating THN into everyday work without continuing the trial.

Incorporating THN into everyday practice may potentially remove some of the barriers associated with the trial (e.g. difficulty in consenting and training high-risk opioid users, choosing the best method to provide staff with kits, cascading the intervention in a setting with high staff turnover) and may encourage more widespread use when considered normal practice rather than research. Provision of training to wider staff groups may also help to mitigate negative attitudes towards opioid users that may hinder provision of the intervention. Similarly, provision of THN kits to friends and family may be more beneficial and reduce the problems associated with recruiting patients during overdose.