We identified six main themes that explain whether a full RCT of THN distribution via emergency settings is likely to be feasible and acceptable.
Staff and service users understood the aims of the trial and how it related to their work practices/lives and were broadly supportive of the intervention as a low-risk, easy to use intervention. Participants perceived multiple potential benefits to the intervention, largely in terms of reducing mortality and morbidity, but also wider benefits to the health service such as reduced ED attendance and ambulance journeys for future overdose.
If it will free up ambulance resources for genuine people. (Service user 8, Site 1)
And it is – I think it would be beneficial for all of us. I think we all would collectively agree that, you know, if we could get more people to sort of take it up, then it would hopefully, certainly reduce the effort that we have to go through sometimes to resuscitate these people. (ED nurse Ambulance 2)
The reduction of fatal overdoses, to us, makes it worthwhile straight away [Paramedic, ED1 focus group]
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. [ED nurse/paramedic, Ambulance Service 2]
Service users reported significant experience of overdose (experienced personally or witnessed) and high levels of awareness and understanding of overdose management (e.g. first aid, administering CPR), including the role of THN in overdose reversal. They described personal experiences of either giving somebody else THN, witnessing its use or having received it themselves.
“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”. [Service User 4, Site 3]
“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”. [Service User 2, Site 3]
Witnessing the impact of naloxone in opioid overdose reversal helped both staff and service users understand the benefits and impact of THN as an intervention (HU01, staff), with paramedics describing how attending overdoses where THN had been delivered made their job easier. Service users perceived overdose as a recognised but unacceptable side-effect of opioid use and highly valued naloxone as an intervention that could save lives. Both sets of stakeholders strongly welcomed the opportunity to widen access to THN and reduce potential harms associated with overdose.
“Because I knew that it saved my mate’s life before I’m more than willing to have this on me”. (Service user 1, Site 2)
“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”. [Paramedic, Ambulance 2]
2. THN offered opportunities for empowering a population who were seen as having low levels of self-efficacy.
Participants perceived the intervention to have potential to increase self-efficacy and empower both service users and their peer and support groups. Service users described how having a THN kit made them feel more secure and confident in dealing with friends or family who used opioids, providing a more immediate response than an ambulance. Staff described how the provision of THN gave them a positive sense of being able to help a population for whom they felt they could offer little support
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”. [Service User 5, Site 2]
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. [Paramedic, Ambulance 1]
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. [ED doctor, ED1 interview]
Both ED staff and paramedics viewed the delivery of THN as compatible with their job role. Paramedics in particular welcomed the opportunity to expand their scope of practice and increase the value of their interactions with patients. Some ED and paramedic staff viewed the interaction when delivering THN training as an opportunity for them to encourage users to engage in further treatment and health promotion conversations with a hard-to-reach population who may otherwise have little contact with health services
Even if 10 people refuse it, if one takes it and it helps them then that is a good thing
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. [Paramedic, ED1 interview]
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.[ED doctor, site 1 interview]
3. Participants supported widening access to THN but had concerns about limited opportunities for engaging patients via emergency services.
Staff and users of opioids supported widening access to THN, although staff had some concerns about the potential to deliver significant increases in access through emergency settings. Whilst delivering THN in emergency settings offered opportunities to access populations who might not otherwise obtain THN (e.g. those not accessing community drug services etc.) there were concerns that patients coming out of overdose were not necessarily receptive to discussing how to use THN at this stage, often being confused or aggressive.
Yeah. A lot of the time it's those patients who then become quite aggressive, very sort of disrespectful. And when someone’s shouting and screaming at you, it's very hard to – (Role not reported, Focus group ED1)
And often, if we give them such you know, a rapid reversal of the opioid, 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. [Paramedic/ED nurse, Ambulance 2]
Those using opioids acknowledged difficulties in engaging with healthcare professionals at this stage due to physical symptoms associated with overdose reversal, and immediate concerns about obtaining further opioids to combat these feelings. However, they recognised this as momentary and a necessary repercussion, given the alternative.
I ended up giving her a second dose and she came round, and she was a bit ratty with me and, you know, I was glad I did it, really. Afterwards, not that day, but afterwards, she agreed that I’d done the right thing. (Service User 5, Site 2)
I think I’d still – knowing that, still use it [THN] 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. (Service User 9, Site 2)
Any person, I’d rather them be violent than die. (Service User 4, site 1)
Some reported reluctance to travel in an ambulance, attend the ED or even contact emergency services, due to concerns about being in possession of drugs when police were present, or unpleasant withdrawal effects following Naloxone administration. They recognised the potentially beneficial role for THN distribution by ambulance services but did not reflect on how the ED might usefully provide THN, lacking experience of ED attendance post overdose. Staff perceived opportunities for ambulance staff to deliver THN to be potentially greater than for ED staff, partly due to higher contact rates, but also due to having more contact within the community and opportunities to engage with friends and family.
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?” (Service User 2, site 2)
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. [ED Doctor, site 1 Focus Group]
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 [Paramedic, ED 1 interview]
4. Procedural problems and high levels of patient refusal contributed to low trial recruitment.
The trial struggled to recruit staff who could recruit patients, and patients themselves, principally due to procedural problems relating to the timing and processes of the trial. Whilst the intervention was described as well resourced, with easy to follow training, engagement of staff differed between the two EDs. One ED recruited few staff and did not engage with the qualitative work. The other ED had a proactive research lead who championed the trial, which resulted in greater staff engagement and willingness counter problems in recruiting patients (e.g. engaging known opioid users attending ED).
High staff turnover in both ambulance services and EDs resulted in difficulties recruiting and training enough staff for the trial to be adequately cascaded and maintained. This was exacerbated by an extended recruitment period due to the COVID-19 pandemic which caused the trial to be paused, combined with a reported reduction in number of overdoses during the national lockdown. Recruitment pauses early in the trial due to protocol changes also meant staff were unaware when the trial was reopened to recruitment so potential patients were missed.
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.” [ED nurse, ED1 interview]
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. [Paramedic, ED1]
Recruitment protocols specified patients could be recruited if fully conscious. However, ambulance crews reported that management protocols for opioid overdose recommended keeping patients from fully coming out of overdose so that they were safe but not fully alert, which meant they were unable to recruit and consent them. Staff also reported high levels of patient refusal, partly due to difficulties in engaging during overdose, but also due to patients stating they already owned a THN kit that had been issued in the community.
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. [Paramedic/ED nurse, Ambulance 2]
5. Limited wider commitment and other competing priorities influenced recruitment.
Staff recruitment to the trial was limited. Participants indicated that the beliefs and behaviours required to enable widespread acceptance of the intervention may not have been held by all colleagues, with some evidence of wider scepticism about the provision of THN by emergency services. Concerns arose from doubts about the ability to make a significant difference at a population level and about the ‘safety net’ effect, suspecting opioid users might take a higher dose, when knowing Naloxone is on hand should they overdose. Some service users acknowledged this risk, but also reported opioid use was dictated by affordability.
“You can only take what you can afford at the end of the day”. [Service user 8, Site 1]
“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.” [Paramedic, Ambulance 2]
“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”. [Paramedic, Ambulance 1]
Other priorities during the period also detracted from the trial. Notably, the impact of the COVID-19 pandemic on emergency services staff left them with limited energy for what was perceived as ‘additional’ work. The timing of the TIME trial also coincided with a number of competing trials whose topics may have been perceived to be more appealing or ‘sexier’ (Paramedic, Ambulance 1).
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. [ED doctor, ED1 interview]
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”. [Paramedic, Ambulance 1]
6. Distribution of THN by emergency services should be enabled but benefits are unlikely to be measurable within a larger RCT.
Staff did not perceive widespread benefits to undertaking a full trial, due to difficulties in recruiting patients, as well as difficulties assessing the outcomes of the trial. The proliferation of THN kits distributed in the community by local services also meant that it would be difficult to attribute any change in outcomes to the distribution of kits by emergency services. Service users similarly perceived other channels (e.g. pharmacy) to be more appropriate for receiving THN.
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.[ED doctor, ED 1]
I think the chemist [good place to get THN] ‘cos where are they going to get their pins [needles] from. [Service User 5, site 1]
However, both staff and people using opiates welcomed the incorporation of THN into their everyday practice, particularly if this could be expanded to incorporate friends and family into the distribution and other ambulance clinicians (e.g. ambulance technicians) being trained to provide the kits. Expanding the distribution of THN by emergency services was perceived as a low cost, low-risk intervention that may be highly beneficial to a small subset of opiate users who would not otherwise access THN (e.g. those not in contact with community drug services).
I think it’s totally compatible with normal ED, a specific group of patients, definitely. […] The more normal it comes, the quicker you can do it. So like any intervention that comes in and is new, it’s difficult at first but then it gets easier as time goes on. [ED nurse, ED1 interview]
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 opioid overdose, that is just part of their patient journey, it’s supposed to be part of their assessment and treatment, two parts. [ED doctor, ED 1 focus group]
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. [Paramedic, Ambulance 1 interview]