Blood Transfusion Clinical Trial
Official title:
Cluster-Randomised Controlled Trial of a Simple Intervention to Prevent Bedside Checking Errors in Blood Transfusion
This study concerns the safety of blood transfusion. Prior to transfusion, staff should
perform a number of essential safety checks to ensure that the correct patient is receiving
the correct blood product. Evidence suggests that these safety checks are not always done.
This study has been designed to assess the effect of a simple intervention on the
performance of the bedside safety check.
The hypothesis is that a simple intervention will improve the performance of the bedside
check.
The local collaborator at each participating hospital will identify two clinical areas
comparable for the following elements: similar hours of service, similar use of red cells,
similar level of intensity, and similar nurse-to-patient staffing ratios. For the purposes
of this study, a clinical area is defined as a discrete area where one type of clinical care
takes place. Comparability will be established by completion of a checklist.
The local collaborator will transmit comparability data to the study co-ordinator who will
pass it on to a nominated medical consultant (Professor Mike Murphy) and the study
statistician. If both parties are satisfied that the two clinical areas are comparable,
confirmation will be transmitted to the local collaborator together with authority to
commence the two-week baseline audit. Once the baseline is complete the local collaborator
will contact the statistician, via the co-ordinator, to be informed of the area for
intervention. The local collaborator will then inform the blood bank of the intervention
area.
The intervention will be applied to one clinical area or ward in each participating
hospital. Both clinical areas will be audited during a two-week baseline observation period.
The two areas will then be randomly allocated to either the intervention of labeled blood
bags or no intervention. Auditing will carry on in both areas until 2 weeks after the
intervention has been introduced. To assess the longer-term impact of the intervention,
there will be a further two-week period of audit 8 weeks from the start of the intervention.
The intervention will be carried out for the full 10-week period.
The randomized comparison will be based on the data collected in the 2-week period after one
area has received the labeled bags, and both areas have been observed by an observer for the
same length of time. Thus the effect of the intervention will be separated from any initial
effect that the observer may have on bedside checking practice. This comparison will also be
made on the long-term audit data collected at 8-weeks.
The intervention under investigation is a simple label applied to the blood bag in such a
way to cover (obstruct entry) the "ports" used to administer blood. The label will be
applied to units of crossmatched red cells only. The position of the label will require that
the user remove the label to administer the red cells. The label will state: "STOP: Check
the patient's wristband". The wording will be translated to the appropriate language as
necessary.
Observers (auditors)- not blinded to the test or control areas - will be asked to audit the
bedside check at the time of transfusion. This will be done by direct observation. The
auditor will take up a position to observe practice and will therefore be obvious to the
staff. However the auditor will not participate in the transfusion check, not answer
questions, and not reveal observed errors in the check (unless they observe that the wrong
blood will be transfused, in which case they should intervene). Observations will be
recorded on the data form.
Participants are invited from Europe, North America, South America, Asia and Australia. The
target is for at least 15 hospitals.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label
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