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Table 2 Proposed solutions, linked to the barriers/enablers they address and the associated APEASE criteria

From: Behavioural optimisation to address trial conduct challenges: case study in the UK-REBOA trial

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