Sample characteristics
Seventeen participants were interviewed across both phases which included participants from 8 sites and the majority identified as Trauma Consultants (n=7, 41.18%) (see Table 1). One participant was interviewed in both Phase 1 and 2 as they provided initial perspectives on early process problems and later experiences of more established trial process problems. Taken together, the interviews lasted an average of 37 minutes, ranging between approximately 22 minutes – 1 hour.
Table 1. Participant demographics for both phases of the study.
Characteristic
|
Phase 1
|
Phase 2
|
Total
|
N
|
13
|
5
|
18*
|
Sites
|
5
|
4
|
8*
|
Roles
|
|
|
|
Trauma Consultant
|
6
|
2
|
7*
|
Trauma Surgeon
|
2
|
-
|
2
|
Trauma Registrar
|
2
|
-
|
2
|
Research Nurse
|
2
|
1
|
3
|
Radiologist
|
1
|
-
|
1
|
Trauma Anaesthetist
|
-
|
2
|
2
|
*1 participant interviewed in both Phase 1 and 2.
The behavioural diagnosis of trial process problems for recruitment of patients in the UK-REBOA trial and in the delivery of the REBOA intervention are described below. The proposed behavioural solutions, designed to mitigate challenges and enhance opportunities (process problem ‘treatment’), are then presented.
Behavioural investigation: diagnosing the trial process problems for trial recruitment and intervention delivery.
Six of the 14 TDF domains were considered relevant to the processes of recruitment to the UK-REBOA trial and to the processes entailed in delivering the trial intervention (the deployment of the REBOA catheter), specifically: Skills; Environmental context and resources; Beliefs about capabilities; Beliefs about consequences; Social influences; and Memory, attention, and decision processes. Thirty-eight belief statements were identified across the six domains. The TDF domains are presented in detail below. An extended table containing the content and frequency of all TDF domains and associated belief statements is provided in Additional file 3.
Skills required for successful recruitment and intervention delivery
The skill in recognising a patient who might benefit from REBOA (and thus who would be eligible to be randomised) was reported by participants to influence both recruitment of patients to the trial and delivery of the REBOA intervention.
“… you need to have had a reasonable, you know, a good few years of resus [resuscitative] experience to be able to recognise a very sick, bleeding trauma patient and who might benefit from that point of view.” Participant 17, Trauma Consultant, Site 6.
However, some participants deemed the ability to recognise eligible patients as less of a barrier to trial recruitment and more of a generic professional skill-set that is common to certain roles within trauma care:
“I think you need the generic professional skill of recognising what a critically sick bleeding patient looks like, but that skill I would say is common…it’s common to the skill set of people working on the front line in modern trauma care, so ED [emergency department] positions and trauma anaesthetist.” Participant 9, Anaesthetist, Site 8.
While participants described the process of delivering the REBOA intervention as technical, it was also deemed to be a transferrable skill that may be developed overtime through the delivery of similar interventions. Relatedly, concerns about maintaining competency due to the low frequency of potentially eligible patients who require REBOA was linked to some of the reported issues surrounding the insertion of REBOA and recognising patient eligibility outside of a simulated context:
“… but I think ultimately the issue is going to be numbers and maintaining training competencies in a system that less than a third inclusion criteria come much reduced. You know maintaining competence.” Participant 10, Trauma Consultant, Site 3.
Environment, context and resources impacts on recruitment and intervention delivery
In addition to the reported skill-based difficulties in maintaining competency due to low throughput of cases, the scarcity of potential REBOA cases was also referenced as adding a further layer of complexity to recruitment and intervention delivery.
“I think another difficulty with this group of patients, is we’re looking at the absolute tip of the iceberg, in terms of the severity of trauma patients, so it’s relatively rare that patients are that sick. It might be 5% of all of them – the code red patients. The code red patients at [hospital], which I think is pretty busy, we’ve got maybe four or five a week. You’re talking about an event that happens maybe once a month, maybe less.” Participant 6, Clinical Research Fellow, Site 5.
One participant highlighted the contextual differences in patient demographics across various emergency departments in the UK, with some experiencing a greater throughput of potential REBOA cases and the direct influence this has on recruitment potential.
The majority of participants indicated that the ability to both recruit patients to the trial and deliver REBOA depended on staff availability. In terms of recruitment and the intricacies involved in key processes such as screening, many participants highlighted the value of Research Nurses and Clinical Fellows, sometimes citing the lack of availability of individuals occupying these specific roles as a barrier. Similarly, the lack of staff available on a 24/7 basis who are trained in the conduct of the trial and delivery of the REBOA intervention was also cited as a barrier to recruitment and intervention delivery.
“I think what I really mean is that randomisations of the trial might not be available 24/7 in our hospital because at any one point in the cycle or the clock, you may not have somebody on there that’s trained in the methodology of the trial or the intervention.” Participant 9, Site 8, Trauma Anaesthetist.
The clinical context of REBOA (i.e. emergency trauma care) was noted by participants as inherently stressful and fast paced, which could sometimes act as a barrier to both recruitment and intervention delivery.
“… in the patient who is crashing, and everything is going haywire, and they are literally about to die, again, people will say, we’ve got to do something, and REBOA is obviously an option. So, the window to actually get those patients we found where randomisation is… where patients were eligible, and REBOA is feasible is very difficult.” Participant 13, Trauma Consultant, Site 4.
Beliefs about clinicians’ capabilities to deliver REBOA
Linked to descriptions of the skill-sets required to deliver REBOA, the scarcity of eligible cases and 24/7 staff availability were comments associated with participants beliefs about capabilities to perform REBOA. A lack of confidence was acknowledged by clinicians who were (or would be) responsible for delivering the intervention, highlighting concerns over personal ability in a real-life setting. In addition, clinical staff who assist in the delivery of the REBOA intervention, also reported their beliefs regarding others’ abilities to deliver the intervention appropriately with reference to the lack of opportunity to refine delivery through practice.
“I think most people who are in the game are concerned about or have nervousness around is actually once the [randomisation] app says, you know use REBOA, that’s where people’s blood vessels start to go up a bit! In terms of am I going to get it in right? Am I going to do it right, that sort of thing. I think, having never done it in anger before, but only as part of the training scenario.” Participant 7, Trauma Consultant, Site 3.
Beliefs about the consequences of REBOA recruitment and intervention delivery
The majority of participants indicated that they believed the REBOA intervention could be beneficial to many patients. In addition, some participants recognised the reputational benefits associated with trial involvement, such as opportunities for emergency departments to showcase their contribution to research. Together, these beliefs motivated site staff to recruit patients to the trial.
“Stuff that would encourage me is that we would be sort of upping our game in trauma by recruiting patients and by contributing to this trial. I think there’s also a bit of a reputational advantage for the department, for the Emergency Department and the trauma service to show other services that, you know, we are taking part in research even during stressful times [global pandemic] and I think that’s sort of a badge of honour.” Participant 3, Trauma Consultant, Site 6.
Many participants discussed their concerns around patient eligibility with particular reference to diagnosing exsanguinating haemorrhage. In addition, some participants indicated that people could hold different views about patient eligibility. Sometimes this could act as a barrier to trial recruitment and intervention delivery.
“…I think it’s going to take quite a bit of work before we work out and we can prove how you diagnose who is genuinely exsanguinating as opposed to who is bleeding a bit… and then how you can go about predicting which patients are associated with a need for this kind of procedure and those which actually would have been alright without it.” Participant 2, Trauma Consultant, Site 4.
When considering challenges around intervention delivery, several participants acknowledged that the REBOA intervention may cause complications. Anticipation of negative side effects sometimes affected decisions to deliver the intervention. One Trauma Consultant suggested that the anticipatory negative consequences impact decisions to deliver the intervention as well as feelings of nervousness amongst first time operators, which is linked to beliefs about capabilities:
“… so I’ve talked about worrying about side effects haven’t I and that affects your decision making to do it, I think the other thing is that I think operators would be nervous about their first time…” Participant 5, Trauma Consultant, Site 6.
Social influences of REBOA recruitment and intervention delivery
Many participants indicated that individuals within their trauma teams often exhibited different levels of equipoise, with some members having a clear preference for either delivering REBOA (or not) to treat eligible patients. This was often linked to beliefs about patient eligibility.
“…some doctors that are very on board with it and really want to try, but it’s a numbers game and I feel like if the senior doctors that have been here longer, some of them don’t like it and therefore that carries more sway than anything...” Participant 8, Research Nurse, Site 1.
Nevertheless, one participant suggested the presence of collective equipoise amongst their team, whereby a preference for REBOA delivery exhibited by some were balanced by clinicians who adopted a more cautious approach.
“There was a bit of friction within the hospital in terms of whether we should be doing REBOA, who does REBOA. The trauma surgeons are quite keen that it’s not done too liberally. Many of the pre-hospital physicians are quite pro-REBOA, and I think that the discussions that happen on an institutional level bear out those differences of opinion.” Participant 6, Clinical Research Fellow, Site 5.
In addition to the influences of others with regard to equipoise and its impact on recruitment, other social influences also impacted on intervention delivery. Participants cited their observations of the clinical team possessing doubts about REBOA recruitment/intervention delivery. This was attributed to their collective worry about the complications that could occur following REBOA. However, the majority of participants indicated that their trauma teams were generally enthusiastic about their participation in the REBOA trial, often expressing altruistic motivations for trial participation. Many participants also acknowledged their appreciation of the trauma-expert delivered training received as a result of their role within the trial.
“It’s been a very good way for us in [hospital] to work with the trial team and access that expertise. Certainly, when they came and did the training day, it was almost less about REBOA, and more about we’ve got a couple of really top-drawer trauma experts just talking about trauma and cases for us, and the feedback for that training day was outstanding…I think there’s a number of perhaps unwitting side effects to all of this, really, in terms of generating dialogue, generating education, that is very, very important. Perhaps the trial didn’t set out to do that, but it’s achieved that.” Participant 15, Trauma Consultant, Site 8.
Memory, attention and decision-making processes during the conduct of REBOA trial delivery
Participants’ descriptions of past experiences of trial recruitment highlighted a few discrepancies with regards to when site staff decide to deploy the REBOA intervention. Sometimes this was linked to difficulties in judging patient eligibility (see above), which either provoked hesitancy or prompted premature decisions to randomise when the patient was subsequently perceived to no longer require REBOA.
“I think we got a little bit ahead of ourselves in the heat of the moment and randomised the patient. We didn’t actually, and weren’t stupid enough to put the REBOA balloon in having realised the patient probably didn’t need it. We discussed all of this at length with our [name of PI and deputy] after the event, and worked it through.” Participant 7, Trauma Consultant, Site 3.
As specified previously, REBOA is typically conducted in a fast-paced, stressful environment by clinicians who reportedly have few opportunities to master the technique outside of a simulated setting. Consequently, the actual delivery of the REBOA intervention was often reported by participants to require significant mental resources (e.g. concentration and memory).
“You need the bandwidth when you’re standing at the end of the bed to get a real global appreciation of what’s going on, which is what we always encourage from trauma team leaders anyway. But if you get stuck in doing something practical or you’re helping out with the airway or a chest intervention or something, then that’s going to make life difficult for yourself.” Participant 15, Trauma Consultant, Site 8.
In addition, the dual act of considering the intricacies of randomisation, such as locating the recruitment app, and the conduct of the REBOA intervention within an emergency department setting was also considered challenging.
Behavioural solutions: ‘treating’ the trial process problems through development and implementation of evidence-based strategies.
We identified twenty-four potential BCTs that could support REBOA trial recruitment and clinical intervention delivery based on the barriers and enablers identified from the TDF diagnosis phase. Table 2 provides a detailed overview of the proposed solutions, first by behavioural solution focus (i.e. Training, Environmental Restructuring and Enablement), followed by solution content, linked BCTs, beliefs statements to illustrate how the interview findings informed the solution development, and the APEASE assessment. Whilst many of the identified barriers are actionable through development of targeted solutions, it is important to recognise that some barriers (such as the need for dedicated research nurses or clinical research fellows, or a 24/7 service to deliver the REBOA intervention) were not practical within this project and talk to wider infrastructure support costs for research more generally. Therefore, these challenges were not prioritised for solution development within the UK-REBOA trial. The priority evidence-based solutions identified included a range of potential strategies. Some of these potential solutions were already active within existing trial practices (e.g. prompt sheets describing recruitment and intervention delivery targeting the memory, attention, and decision processes domain), but novel strategies were also identified.
One of the potential solutions to address several barriers were adaptations or updates to trial training packages. The behavioural investigation identified the need to target aspects already covered by the site training. For example, step by step instructions on how to randomise patients and perform REBOA (BCT Demonstration of the behaviour). Novel areas to target included the impact of altruistic emotions by highlighting staff contributions to valuable research that could change clinical practice (BCT Information about emotional consequences), and reminding staff they have successfully recruited participants and/or performed REBOA in simulation or real life (BCT Focus on past success).
We also identified the requirement for solutions that could be applied to restructure the physical and social environment and enact other processes and procedures to enable recruitment and intervention delivery. One of the solutions developed to potentially address the relevant barriers was a bespoke infographic (see Additional file 4) designed to target variations in individual equipoise amongst trauma teams (TDF Social Influences, Beliefs about consequences). The infographic contained BCTs that reinforced the purpose of the trial with information about the social and environmental consequences of recruitment/REBOA intervention delivery (BCT Information about social and environmental consequences), as well as contact details of the clinical CI and Training Lead to indicate the support available (BCT Social support, practical). The infographic was distributed to all recruiting sites and to be shared amongst staff involved in the trial (electronic and paper copies for sharing).
Other potential solutions proposed included upscaling the use of mannequins to facilitate skills acquisition/maintenance via simulating trial recruitment/intervention delivery (BCT Adding objects to the environment). Also, the development of a single page proforma used as learning tool for staff to share experiences of trial randomisations, including anonymised case details about patient eligibility and procedural descriptions of recruitment/intervention delivery (BCTs Social support (practical) and Social comparison). The proformas could prompt staff to proactively plan for any events that may occur unexpectedly on the basis of their past experiences, as well as consider solutions to overcome challenges that may arise in the future (BCTs Action planning and Problem solving). Findings also supported the ongoing praising of staff for their efforts in recruitment and intervention delivery when applicable (BCT Social reward).
[Table 2 here: Proposed solutions, linked to the barriers/enablers they address and the associated APEASE criteria]