Introduction
Methods
Context: the UK-REBOA trial
Study design
Participants
Data collection
Data analysis
Identification of salient TDF domains
Identification of Behaviour Change Techniques and development of potential solutions to help improve trial processes
Results
Sample characteristics
Characteristic | Phase 1 | Phase 2 | Total |
---|---|---|---|
N | 13 | 5 | 18 a |
Sites | 5 | 4 | 8 a |
Roles | |||
Trauma consultant | 6 | 2 | 7 a |
Trauma surgeon | 2 | - | 2 |
Trauma registrar | 2 | - | 2 |
Research nurse | 2 | 1 | 3 |
Radiologist | 1 | - | 1 |
Trauma anaesthetist | - | 2 | 2 |
Behavioural investigation: diagnosing the trial process problems for trial recruitment and intervention delivery
Skills required for successful recruitment and intervention delivery
… 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.
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.
… 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
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.
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.
… 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
Beliefs about the consequences of REBOA recruitment and intervention delivery
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.
…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.
… 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
…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.
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.
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
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.
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.
Behavioural solutions: ‘treating’ the trial process problems through development and implementation of evidence-based strategies
Proposed solution(s) | Proposed content | Selected BCT(s) (domain-relevant/supplementary) | Belief statements (salient barriers/enablers, linked to TDF domains) | Inclusion record (including APEASE criteria) |
---|---|---|---|---|
Training | Target altruistic emotions — express satisfaction of being part of a trial which will influence clinical practice Encourage reflection of the pros/cons to recruitment in the trial generally. Including advantages of knowing which clinical method is most effective. Highlight how the research will influence clinical practice. Remind staff about the potential benefits of REBOA to patients with traumatic injury, despite the associated risks. Also benefits of not doing REBOA — standard care. The purpose of the trial is to find out which method is best. Highlight that staff are contributing to valuable research which will also benefit the reputation of each institute. Present case studies of real-life examples where patients have been treated with REBOA and standard care, and highlight the valuable contribution of the trial Link the benefit of taking part in the trial to anticipated regrets of failing to recruit eligible patients. Remind staff of the scarcity of cases. Highlight the requirement to address the trial research question | 5.6. Information about emotional consequences 9.2. Pros and cons 5.1. Information about health consequences 5.3. Information about social and environmental consequences 5.2. Salience of consequences 5.5. Anticipated regret | ‘Reputational benefit for the institute associated with being able to recruit patients and deploy REBOA’ (TDF Beliefs about consequences) ‘REBOA may be beneficial’ (TDF Beliefs about consequences) ‘REBOA may cause complications’ (TDF Beliefs about consequences) ‘It can be difficult to define exsanguinating haemorrhage’ (TDF Beliefs about consequences) | Include BCTs 5.6., 9.2., 3.2., 5.1., 5.2.: All APEASE criteria met Exclude BCT 5.5: May not be acceptable. Many valid reasons for not recruiting eligible patients, external, out-with control. APEASE Acceptability, Equity and Side-Effects criteria not met |
Training | Include step-by-step instructions on how to recognise eligibility and perform REBOA: provide a demonstration by presenting video clips. All sites have to agree on eligibility criteria. Provide case study examples Set easy-to-achieve tasks (e.g. the areas which site staff find simple to complete, such as navigating the randomisation app) and progress to more complex steps, such as monitoring eligibility and performing REBOA | 6.1. Demonstration of the behaviour 8.7. Graded tasks 8.1. Behavioural practice/rehearsal | ‘Recognising an eligible patient requires expertise’ (TDF Skills) ‘Insertion of REBOA can be technical’ (TDF Skills) ‘Concerns about competency due to low throughput of cases’ (TDF Skills) | Include all BCTs (already delivered during on-site training): APEASE criteria met |
Training | Incorporate advice on how to reduce the cognitive load of performing REBOA and randomising a patient. This can include assigning other tasks completed simultaneously to different members of the team | 11.3. Conserving mental resources | ‘You need to remember technical aspects of REBOA’ (TDF Memory Attention and Decision Processes) ‘Our team is inclined to wait to see if our patient requires REBOA’ (TDF Memory Attention and Decision Processes) | |
Environmental restructuring | Social prompt: Assign an individual to prompt REBOA randomisation/delivery when a code red is flagged. This could include prompting eligibility assessment or technical aspects of REBOA. Remind healthcare professionals of the protocol. Encourage the use of memory aid sheets to facilitate memory of REBOA recruitment and the procedure. Can include provision of cue cards to be slotted into staff lanyards Sites could purchase a mannequin/or recycle use of existing mannequin to practice REBOA on a weekly basis. Arrange for colleagues to provide practical help to recruitment and delivery of REBOA in each shift. This may include providing contact details of those who can help during out-of-hours Assign REBOA champion roles at each site and highlight support available during team meetings Ensure staff have a device with the app readily accessible for randomisation and gather essential equipment or prepare a REBOA trolley to assist in the delivery of the intervention This could also include a diagram of the ideal positioning of staff during a code red call | 7.1. Prompts/cues 12.5. Adding objects to the environment 3.2. Social support (practical) 12.2. Restructuring the social environment 12.5. Adding objects to the environment 12.6. Body changes 12.1. Restructuring the physical environment | The clinical context for REBOA is inherently stressful and fast-paced (TDF Environmental Context and Resources) ‘There are so few patients who require REBOA’ (TDF Environmental Context and Resources) ‘The ability to recruit depends on staff availability’ (TDF Environmental Context and Resources) | Include all BCTs: APEASE criteria met. Whilst some BCTs were already incorporated in trial practices, it was recommended that delivery of all BCTs should be monitored to ensure continuous implementation |
Enablement | Encourage staff to praise local efforts of recruitment and REBOA delivery when applicable. Praise can also be communicated via Email, as well as during local PI meetings Encourage sites to provide monthly updates on the progress of REBOA trial recruitment and intervention delivery during trial meetings. Facilitate detailed discussion about recruitment procedures: ask staff to provide a description of the latest recruitment cases including ‘near misses’ (when applicable). CIs to provide information about whether they approve of the procedures/decisions adopted Prompt discussion of what went well and what might have been done differently. Include action plans to tackle similar situations in the future Maintain the enthusiasm of REBOA by advising staff to encourage others to recruit and randomise eligible participants See examples listed above 5.3.: designed to target mixed levels of team equipoise (beliefs about the consequences of REBOA intervention delivery). Delivered as bespoke infographic to be distributed to all site staff. Provide contact details of Clinical CI and Clinical Lead: highlight support available | 10.4. Social reward 6.3. Information about others’ approval 3.2. Social support (practical) 6.2. Social comparison 1.2. Problem solving 1.4. Action planning 3.1. Social support (unspecified, practical) 5.3. Information about social and environmental consequences 3.2. Social support (practical) | ‘Our team is enthusiastic about the REBOA trial’ (TDF Social influences) ‘People can hold different views about patient eligibility’ (TDF Social influences) ‘Our team has mixed levels of individual equipoise’ (TDF Social influences, TDF Beliefs about Consequences) | Include: all APEASE criteria met Whilst some BCTs were already incorporated in trial practices, it was recommended that delivery of all BCTs should be monitored to ensure continuous implementation |
Persuasion Enablement | Remind staff that they have successfully performed REBOA and recruited participants in simulation and/or in real life Enabled by PIs Local principal investigators (PIs) can actively persuade relevant staff members that they are capable of performing the REBOA intervention during conversations/meetings. Highlight transferable skills of trial recruitment — include the successful past experience of trial involvement Encourage staff to practice positive self-talk as a team: this could include discussing one’s own achievements/successes in a group setting. PIs to deliver | 15.3. Focus on past success *can also be incorporated into training 15.1. Verbal persuasion about capability 15.4. Self-talk | ‘Clinicians have to be confident to deliver REBOA; this can influence recruitment’ (TDF Beliefs about capabilities) ‘There is lots of nervousness around delivering REBOA related to personal abilities’ (TDF Beliefs about capabilities) | Exclude: Difficult to implement. Depends on factors less amenable to change – e.g. PI personality and workplace culture BCTs 15.3. and 15.1. can instead be incorporated via trial Training practices APEASE Effectiveness criteria not met APEASE Practicability criteria not met for BCT 15.4. Difficult to implement in a trauma care setting |
•How did you identify patients eligible for REBOA? |
•Can you provide step-by-step information regarding the procedures you followed before/after randomisation? |
•What were the challenges you faced during this case? |
•Which aspects of recruitment/intervention delivery went well? Why? |
•Is there anything you would do differently if a similar case arose in the future? (can you think of any solutions?) |