Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2005-04-30
2005-12-31
Brief Summary
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The hypothesis is that a simple intervention will improve the performance of the bedside check.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
NONE
Interventions
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Label applied to blood bag
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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BEST research collaborative
UNKNOWN
Dartmouth-Hitchcock Medical Center
OTHER
Principal Investigators
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Walter Dzik, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital, USA
Mike F Murphy, FRCPath, MD
Role: PRINCIPAL_INVESTIGATOR
National Blood Service, England
Locations
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LA County and USC Medical Centre
Los Angeles, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Centre
Boston, Massachusetts, United States
Dartmouth-Hitchcock Medical Centre
Lebanon, New Hampshire, United States
Cincinnati Children's Hospital Medical Centre
Cincinnati, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Hospital Sirio Libanes Blood Bank
São Paulo, , Brazil
Hamilton Health Sciences
Hamilton, Ontario, Canada
Sunnybrook & Women's Hospital
Toronto, Ontario, Canada
Haukeland University Hospital
Bergen, , Norway
Great Ormond Street
London, , United Kingdom
Countries
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References
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Murphy MF, Casbard AC, Ballard S, Shulman IA, Heddle N, Aubuchon JP, Wendel S, Thomson A, Hervig T, Downes K, Carey PM, Dzik WH; BEST Research Collaborative. Prevention of bedside errors in transfusion medicine (PROBE-TM) study: a cluster-randomized, matched-paired clinical areas trial of a simple intervention to reduce errors in the pretransfusion bedside check. Transfusion. 2007 May;47(5):771-80. doi: 10.1111/j.1537-2995.2007.01189.x.
Related Links
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BEST collaboration
Other Identifiers
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TM-PROBE study
Identifier Type: -
Identifier Source: org_study_id