Environmental challenges and opportunities (COM-B: physical opportunity and physical/psychological capabilities)
critically ill, trauma
HEART ATTACKS, CRITICALLY ILL
In addition to the cultural challenges outlined, participants described other environmental barriers related to conducting pre-hospital trials. Specifically for trauma trials, this included comments related to the lack of eligible patients who require the clinical interventions (limited physical opportunity to recruit), which meant that it was also difficult for staff to retain the appropriate technical skill sets required to deliver trials (including intervention delivery, challenging physical capabilities). Working in a pressurised, fast-paced, often under-staffed, environment could challenge their mental ‘bandwidth’ impacting psychological capabilities to conduct pre-hospital research within this setting.…the research procedures, themselves, may delay delivery of specific aspects of care, or may complicate the care to such an extent that those things that are being done are not done properly. It is a small team, potentially working in a difficult environment with very little bandwidth. Pre-hospital trial researcher 7.Linked to this bandwidth issue, the requirement to design pre-hospital trials with minimal paperwork to reduce the associated workload pressures was also emphasised.... it’s a pressured environment and if we want to get trials off the ground, deliver trials and recruiting in an efficient way, we need to keep the [administrative] demands to a minimum. We’re meant to make it easy for our staff to recruit patients. Pre-hospital trial researcher 6.The logistics around intervention allocation in a pre-hospital environment was also noted as a barrier: many emphasised the difficulties associated with concealing allocation outcome and access to online platforms designed to facilitate randomisation in remote areas. Consideration of the pre-hospital trauma environmental context in relation to consent (i.e. research without prior consent) and how this intersects with cultural or religious considerations and the pace of decision-making required was also identified as a notable challenge to trial conduct.…we spent a fair amount of time in various motorway service stations up and down the country chatting to Jehovah’s Witness hospital liaison people about how not to enrol a Jehovah’s Witness without their consent. Pre-hospital trial researcher 2.Other operational challenges linked to follow-up in relation to patients being randomised to a trial within a pre-hospital setting, but transported to a receiving hospital that was not set up to deliver the trial.…there were occasions when patients were deemed so critically ill that they take them to the nearest hospital. If those nearest hospitals weren’t part of your study, getting as we would be doing professional legal or personal legal representative consent became difficult or impossible, and so we lost a number of patients to follow up because we had no way of obtaining consent. Pre-hospital trial researcher 4…because I guarantee the first patient you recruit will go [sic] another trauma centre and then you’ll have randomised the patient but have no means to capture the follow up data. Pre-hospital trial researcher 3Nevertheless, participants also indicated the opportunities of conducting trials in a pre-hospital setting — the ability to deliver time-sensitive interventions to patients before they arrive in the hospital was regarded as an important implication of pre-hospital care.A lot of interventional treatments in a variety of different conditions are time-sensitive, say heart attacks, there’s a lot of evidence out there that treatments are time-sensitive. The earlier you get them, the better the benefit…so there’s definite benefit in moving treatment forward. That’s the big advantage of pre-hospital trials, is that they are working in that environment before they arrive in hospital… Pre-hospital trial researcher 5.