Table 2 Example of table used for sharing of findings on a monthly basis with the trial team

Trial design

• Problems identified with cross-site working and the basing of research nurses at site 1

• Need to consider additional research nurse resource necessary for night and weekend cover and to work at both sites

• Difficulties integrating additional sites due to the demand on staff time produced by trial design

Trial set-up

• No major problems mentioned about set-up at both sites

• The problem with set-up at one hospital was mainly due to lack of capacity within the Trust: space on wards, ward staff time, research nurse time, hospital site lead did not see it as a priority

Patient screening processes

• It is easier to screen patients during office hours

• Screening patients from ED seen as a helpful process, but easier to do at site 1

• Trials combining multiple screening approaches (face to face, review of patient lists, through clinical teams) identify higher numbers of potential participants [28]

Referral processes

• Doctors working during night shifts often forget to refer patients

• Site 2 experienced delays in referring patients, but this has recently improved

• Some doctors do not agree with the trial (i.e. not convinced about evidence), so they will not refer

• Doctor change-over led to missing patients

• Receiving frequent feedback from the trial team about trial progress and findings was helpful in maintaining engagement of local clinical teams [3, 9]

Informed consent process

• Considered straightforward by staff

• One patient interviewed to date felt all of the information was clear (patient did not know about randomisation, however)

• An ‘open’ informed consent process (allowing the patient to guide the discussion) led to better informed patients [9]

Patient acceptance/refusal

• Patients approached at night were less likely to accept to take part

• Main reasons for refusal: patient in too much discomfort/pain, language barriers. Importance of considering effective analgesia prior to being approached for the study

• Trials including an education component for patients about their conditions showed an increase in recruitment rates [3]

Management of patients on the trial

• No problems identified to date

Patient withdrawal

• Family did not agree

• Patient was discharged prior to 48 h (at least 5 patients stayed less than 48 h)

• Patient was worried about “getting too much fluid”

Patient follow-up

• Some patients do not pick-up the calls

• More difficult to contact people over the Summer

• Sunday afternoon is a good time to contact people

Factors to consider for trial scale-up and embedding into routine clinical practice

• Increase the number of research nurses, so staff can be based at all sites included in trial (ideal number proposed was 5 nurses for two sites)

• Use researcher nurses that live locally to the hospitals to easier to travel at night

• Develop strong relationships with clinical teams at all sites before the trial to ensure engagement in referral and recruitment

• Establish regular meetings across sites to remind doctors about the trial

• Research nurses should be trained in phlebotomy to draw blood at time when phlebotomists are not available

• The ‘machine’ should be based close to the nurses’ office (too far away at site 2)

• Doctors at all sites receive GCP training early so they can deliver the PIS to the patient to avoid travel for the research nurse from home out of hours or across sites during working hours if the patient is not interested in the trial

• The WhatsApp group was seen as a helpful tool

• Better use of clinical surgical CNS to sign-post patients

• Study can be embedded in critical care

• CNS can be involved in supporting patients throughout the trial

• The critical care team might have capacity to incorporate this work in routine practice (as they have a large group of trial nurses)

• Training of clinical teams helping with patient referrals has been identified as a useful strategy to increase recruitment [9]