General Site Queries
Who can/should be Principal Investigator for the ASAP trial?
This will depend on the set-up in individual Trusts. It is likely that the Principal Investigator for the ASAP trial will be from one of the main Specialties involved in pandemic care – i.e. respiratory medicine, infectious diseases, emergency medicine or critical care.
What additional work is involved for clinical and research staff?
The ASAP trial is a pragmatic trial, meaning that every effort has been made to ensure that trial procedures follow standard clinical practice as closely as possible. Additional workload will therefore be minimal.
What resource is available for research nurses etc. to run the study?
The service support element of the trial will be supported by the CLRNs. We recommend early engagement with the CLRN to discuss how the resource will be mobilised in the event of a pandemic.
What is involved for the critical care team?
Critically ill ASAP trial patients may be admitted to the intensive care unit once they have been admitted to hospital and randomised. Patients that are admitted to intensive care will need to continue to receive their study medication to a total of 5 doses (one dose per day). There should be no additional involvement for critical care teams.
Research staff will obtain written consent from the participant before they are discharged from hospital. There are no additional trial-specific procedures. All data required for the trial, including patient outcomes, will be collected from routinely recorded information by research staff at each site.
We are participating in the PAINTED study; can we still participate in the ASAP trial?
We are aware that a number of trial sites are participating in other pandemic research studies/trials, including the PAINTED study with is part of the NIHR pandemic portfolio. Participation in the PAINTED study is not a barrier to participation in the ASAP trial and vice versa. Indeed, co-enrolment to both studies is encouraged. The Critical Care Speciality Group has contributed a paper that describes strategies for co-enrolment into trials. The paper focuses on Critical Care but lots of the principles could be extended to other Specialty areas. The paper may also be useful for Urgent Public Health studies. The full paper “co-enrolment to intensive care studies – a UK perspective” is published in the Journal of the Intensive Care Society.
If your site is participating in any other pandemic research that you think may affect participation in the ASAP trial please contact the ASAP Trial Manager.
Will we need to follow-up the trial participants?
No, not for the purposes of the trial. Once patients have been discharged from hospital, the only follow-up in relation to the ASAP Trial is a postal questionnaire; this will be the responsibility of the Nottingham Clinical Trials Unit. Research staff will need to record patient outcomes up to 30 days from randomisation; hence a regular (weekly) check of hospital IT records will be necessary to identify any notification of patient death or readmission following discharge from hospital.
Do study medication packs needs to be stored at each admission point within the hospital?
Ideally the study medication will need to be stored at each admission point as it will need to be readily accessible to randomise patients quickly. It is expected that in a pandemic there will be insufficient time or resource to be going to a central point, unless the central point is easily accessible by staff at each admission point within the hospital. The medication packs will need to be accessed easily at the point of admission without hindering in any way the normal clinical service, so if the central point does not allow this then you will need to have a storage point at each admission point.
When will we receive the studymedication packs?
IMP study medication packs will only be delivered to trial sites once a decision to activate the trial has been made.
What will the study medication packs contain?
The study medication packs will contain a 75ml bottle of either dexamethasone or placebo, instructions for taking the medicine at home (in case the patient is discharged from hospital within 5 days of being admitted) and a wristband for the patient to help site staff in identifying trial participants. The outside of the box will have a peel off sticker ASAP trial sticker (reminding of the need to write up as a TTO if the patient is sent home within 5 days) for the prescription chart with a reminder underneath to transfer study medication with trial participant.
Is temperature monitoring required?
The study medication should be stored below 30°C and has a shelf life of 12 months at this temperature. There will be no additional requirements for temperature monitoring for trial purposes. Dexamethasone is a licensed product and study medication should be stored appropriately according to standard practice.
Can study medication be stored on the drug trolley?
The study medication will need to be stored in the patient’s bedside locker, not on the drug trolley. Study medication may be prepared in advance for the patient to take home if discharged within 5 days and thus it is to be dispensed as a patient’s own medicine and kept with the patient at all times. Storage of study medication kept on a drug trolley has the potential to be misplaced in a pandemic situation when patients may be moved between wards and/or hospitals. If you envisage any problems being able to comply with this please contact the Trial Manager