Table 2.
Summary checklist of issues to consider in relation to optimising critical care trials/study recruitment.
| 1. Centre/organisational factors |
| a) Can high-level agreements be established regarding research staff time at board and executive level to avoiding mandatory relocation of research staff to the ‘floor’ in staffing crises? |
| b) Is there scope to allow research staff a degree of flexible working across unit, in times of need, to reciprocate for unit staff helping to recruit to trials, enhancing unit cohesion? |
| c) Can the research leads negotiate with NIHR CRN leads to get portfolio contingency funding to bridge gaps or negotiate with R&D for ‘soft monies’? |
| d) Has capacity (unit and R&D) been assessed prior to a new trial? |
| - Can the unit reasonably cope with more studies? |
| - Do the research team have capacity to run more studies? Will R&D infrastructure support new trials and regulatory and approval processes? |
| e) If problems are anticipated embedding trials, can a pilot phase for the trial be considered? |
| f) When research staff allocated to support studies are based outside the critical care team (for example, clinical research facilities) has agreement to provide adequate screening time and frequency been reached? |
| 2. Unit factors |
| a) Staffing: |
| - How have funding arrangements been negotiated at a local level? |
| - Could research staff be funded from critical care budgets if portfolio funding is problematic? |
| - Could secondments or rotational posts be used to aid research staff numbers? |
| b) Communication and support from staff team: |
| - How will patients be identified and who will identify? How can unit staff aid this screening process? |
| - Has the research teams addressed unit concerns regarding equipoise, uncertainty or consent prior to commencing study? |
| - How will intra-trial communication (research team and central study co-ordinators) be considered? |
| - Are there regular, formalised contact meetings and/or teleconferences? |
| - How will intra-ICU communication (research team and clinical team) be considered? Is there regular contact (e.g. via MDT presentations/posters) with clinical colleagues? |
| c) Logistics |
| - How has protocol compliance been addressed at the outset and throughout the study? |
| - Has a co-enrolment agreement been considered with existing and/or other planned trials? |
| - How often is screening undertaken? How can screening be organised to take place more than once a day? |
| 3. Study factors |
| a) Have all the trial resources been accounted for (drug supply/drug storage/out-of-hours laboratory services etc.)? |
| b) Have numbers of potential patients been scoped at a local level for studies with narrow recruitment windows? |
| c) What are the burdens and scheduling of the study and how might this affect potential recruitment? |
| d) Are there any potential concerns about randomisation/placebo or treatment arm preferences that could impinge on recruitment? |
| e) How have trial complexity and understanding been conveyed (to staff and participants); is it easy to understand? |
| f) Who is able to undertake out of hours consent? |
| - Can unit clinicians be trained and GCP-compliant to be able to undertake this? |
| 4. Resources |
| a) Can the research nurses be recruited into/placed on full-time permanent contracts to enhance retention and recruitment? (Local CRNs may be able to help with this). |
| - How can research staff be supported in career development opportunities (e.g. Masters in clinical trials/MRES)? |
| b) Can team initiatives to optimise recruitment be implemented, such as simulation of study recruitment and procedures; unit-based teaching; motivational small reward incentives for unit staff screening? |
| c) How have underlying issues of unit workload been considered within the proposed trial context? |
| - Can additional resources (such as research staff covering staff breaks) be used to encourage a collaborative culture? |
| d) Can the research nurses be trained, through competency-based assessment, to take consent (challenging R&D policy where required) or be principal investigator? |
| 5. Clinician factors |
| a) Can critical care consultants who are leading research negotiate PA/SPA session time to facilitate research? |
| b) Have local lead investigators negotiated with senior clinicians to promote engagement, encourage buy-in and address potential opposition at the outset? |
| 6. Patient/family factors |
| a) Have the wider trial/study burdens for families and patients been fully considered; there may be unforeseen local issues (e.g. transportation for follow-up)? |
| b) Could the scheduling be altered in an amendment submission, without affecting the primary outcome? |
| c) Are there specific randomisation/placebo or treatment preference concerns that need focused attention and education from the research team, including research lead? |
| d) Is the initial approach being carried out by clinicians or researchers? Which is the best for the trial in terms of optimal recruitment potential? |
| e) Is the trial understandable to patients and families; could a trial amendment be made where it is evident that it is difficult to recruit because of understanding? |
| f) Is there a documented process for communicating trial/study information to patients/families? |
| - Are there any peer-assessment/reflective processes that could be used to enhance communication? |