Transfusion Related ComplicationNCT03476005
Proficiency Based Training to Investigate WBIT
A study testing proficiency based progression training in people with Transfusion Related Complication and Wrong Blood in Tube, run by Patrick Henn at 1 site in Ireland.
Trial summary
Incorrect labelling of blood samples occurs at a rate of 1% in the general laboratories and 6% in Blood Transfusion Laboratories. The most serious error 'Wrong Blood in Tube' (WBIT) occurs when blood is taken from the intended patient, but labelled with another patient's details. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Transfusion Related Complication, Wrong Blood in Tube
- What is being tested?
- proficiency based progression training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteIreland
- Study dates
- 5 Jul 2017to 3 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All historical interns blood samples from July to Sept 2016 All interns who receive training and working at Cork University Hospital from July to Sept 2017
Who cannot join
- Interns in 2017 who do not attend for training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technology Enhanced Learning and Proficiency Based Progression to Investigate and Mitigate 'Wrong Blood in Tube' in Our Hospitals; Can we Improve Patient Safety and Reduce Resource Wastage?
Incorrect labelling of blood samples occurs at a rate of 1% in the general laboratories and 6% in Blood Transfusion Laboratories. The most serious error 'Wrong Blood in Tube' (WBIT) occurs when blood is taken from the intended patient, but labelled with another patient's details. Consequences may include, misinterpretation of a patient's diagnosis or clinical status, incorrect referral or treatment of a patient, or in the worst case scenario, incorrect cross matching for blood of the wrong blood group, which may lead to catastrophic outcomes, including death.
The root causes for these errors is failure to identify the patient correctly and failure to correctly label the blood tubes at the bedside. To date, despite significant initiatives, it has proved very difficult to eradicate or reduce the error rate. Our project involves a novel, technology enhanced learning approach using proficiency based progression in a prospective randomised controlled methodology to significantly reduce this error.
Read more
This approach to learning is more efficient and effective than the traditional approach of repeated practice and is made possible with metric-based simulations. This project will reduce the incidence of adverse events and avoidable medical errors associated with sampling and labelling errors including WBITs. This will be achieved by training healthcare practitioners to a proficiency standard in venepuncture. Thereby minimising the failure of health care professionals to identify the patient correctly and failure to correctly label the blood tubes at the bedside.
This project's impact will deliver reduced sampling and labelling errors -including WBITs by a factor of 40-69%. Reductions of this magnitude will have profound national and international implications on how these types of skills are acquired and quality assured. This would result in improved patient safety and savings of over €500,000 at Cork University Hospital and if applied nationally result in exchequer savings of millions of euro annually.
Read the detailed description
The goal of the study is identification, development and operational definition and then validation of phlebotomy performance Metrics which will be used to characterize the optimal performance of healthcare practitioner's execution of phlebotomy. These validated Metrics will serve as an educational and training tool to improve and quality assure phlebotomy training. The validated metrics will be used to produce validated metric-based simulations which will be used to establish a training benchmark based on experienced clinicians' performance. It will also be used to underpin deliberate practice in simulated training.
By introducing proficiency-based progression training supported by technology enhanced learning we aim for reductions in the error rates of wrong blood in tube of 40 to 69%.
Objective 1 To characterize the process of taking a blood sample correctly and the correct process for labelling a blood sample bottle and laboratory request form to reduce the incidence of wrong blood in tube.
This will involve metric development and metric validation of the process of taking a blood sample correctly and the correct process for labelling a blood sample bottle and laboratory request form - as a result of a consultative process, including qualitative analysis of WBIT errors.
Objective 2 To quantitatively define a proficiency benchmark and then to design training to the proficiency standard and assessment of proficiency up to and including real time feedback to the doctor and patient in the clinical arena.
Objective 3 Design a new approach to training including assessment using technology enhanced learning, incorporating online learning and simulation based training of taking a blood sample to a proficiency standard.
Objective 4 To implement the training and assessment in the highest risk groups and document the effectiveness of the intervention.
The training will be delivered to all interns commencing work at Cork University Hospital on July 10th 2017 as proficiency based progression simulation training with additional systematic proximate feedback.
Data from each training group will be identified using the laboratory tracking quality system and using comparison with the historical data from the previous year(s).
Objective 5 To use the research data generated to recommend an evidence based training and competency assessment approach to health care providers in Ireland, together with evidence based individual feedback for any residual errors. This will allow us to internationally address the universal problem of sample mislabeling and WBIT.
- Being tested
- proficiency based progression training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proficiency based progression trainingBehavioural
proficiency based progression training supported by technology enhanced learning
| Study group | Role | What they receive |
|---|---|---|
| Proficiently Trained interns - | Active comparator | Provided with proficiency based progression training supported by technology enhanced learning Receives: Behavioral: proficiency based progression training |
| Historical controls | No intervention | no extra training provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
WBIT
Wrong blood in tube
Measured: 3 months
Secondary outcomes (5)
wrong bottle type
incorrect bottle type used
Measured: 3 months
under filled samples
number of under filled samples which did not allow analysis
Measured: 3 months
clotted samples
Number of clotted samples
Measured: 3 months
haemolysed samples
number of haemolysed haematology samples
Measured: 3 months
Mislabelling
Mislabelling of forms/bottles in blood bank
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start5 Jul 2017
- Primary completion3 Jul 2018
- Study completion3 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfusion Related ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Incidence of wrong blood in tube in interns provided with proficiency based progression training supported by technology enhanced learning in 2017 will be compared with historical controls from the same period in 2016
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patrick Henn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Patrick Henn, University College Cork
- Investigators
- Mary Cahill, MD, Study chair, UCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476005
- Sponsor's protocol ID
- #1710
- Status last verified
- Jul 2018
- First submitted
- 5 Jul 2017
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available by contacting Principal Investigator
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Enhanced Learning and Proficiency Based Progression to Investigate and Mitigate 'Wrong Blood in Tube' in Our Hospitals; Can we Improve Patient Safety and Reduce Resource Wastage?
- ClinicalTrials.gov ID
- NCT03476005
- Acronym / sponsor ID
- #1710
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Patrick HennUniversity, hospital or other
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 3 Jul 2018 (actual)
- Study completion
- 3 Jul 2018 (actual)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Incorrect labelling of blood samples occurs at a rate of 1% in the general laboratories and 6% in Blood Transfusion Laboratories. The most serious error 'Wrong Blood in Tube' (WBIT) occurs when blood is taken from the intended patient, but labelled with another patient's details. Consequences may include, misinterpretation of a patient's diagnosis or clinical status, incorrect referral or treatment of a patient, or in the worst case scenario, incorrect cross matching for blood of the wrong blood group, which may lead to catastrophic outcomes, including death.
The root causes for these errors is failure to identify the patient correctly and failure to correctly label the blood tubes at the bedside. To date, despite significant initiatives, it has proved very difficult to eradicate or reduce the error rate. Our project involves a novel, technology enhanced learning approach using proficiency based progression in a prospective randomised controlled methodology to significantly reduce this error.
This approach to learning is more efficient and effective than the traditional approach of repeated practice and is made possible with metric-based simulations. This project will reduce the incidence of adverse events and avoidable medical errors associated with sampling and labelling errors including WBITs. This will be achieved by training healthcare practitioners to a proficiency standard in venepuncture. Thereby minimising the failure of health care professionals to identify the patient correctly and failure to correctly label the blood tubes at the bedside.
This project's impact will deliver reduced sampling and labelling errors -including WBITs by a factor of 40-69%. Reductions of this magnitude will have profound national and international implications on how these types of skills are acquired and quality assured. This would result in improved patient safety and savings of over €500,000 at Cork University Hospital and if applied nationally result in exchequer savings of millions of euro annually.
Detailed description
The goal of the study is identification, development and operational definition and then validation of phlebotomy performance Metrics which will be used to characterize the optimal performance of healthcare practitioner's execution of phlebotomy. These validated Metrics will serve as an educational and training tool to improve and quality assure phlebotomy training. The validated metrics will be used to produce validated metric-based simulations which will be used to establish a training benchmark based on experienced clinicians' performance. It will also be used to underpin deliberate practice in simulated training.
By introducing proficiency-based progression training supported by technology enhanced learning we aim for reductions in the error rates of wrong blood in tube of 40 to 69%.
Objective 1 To characterize the process of taking a blood sample correctly and the correct process for labelling a blood sample bottle and laboratory request form to reduce the incidence of wrong blood in tube.
This will involve metric development and metric validation of the process of taking a blood sample correctly and the correct process for labelling a blood sample bottle and laboratory request form - as a result of a consultative process, including qualitative analysis of WBIT errors.
Objective 2 To quantitatively define a proficiency benchmark and then to design training to the proficiency standard and assessment of proficiency up to and including real time feedback to the doctor and patient in the clinical arena.
Objective 3 Design a new approach to training including assessment using technology enhanced learning, incorporating online learning and simulation based training of taking a blood sample to a proficiency standard.
Objective 4 To implement the training and assessment in the highest risk groups and document the effectiveness of the intervention.
The training will be delivered to all interns commencing work at Cork University Hospital on July 10th 2017 as proficiency based progression simulation training with additional systematic proximate feedback.
Data from each training group will be identified using the laboratory tracking quality system and using comparison with the historical data from the previous year(s).
Objective 5 To use the research data generated to recommend an evidence based training and competency assessment approach to health care providers in Ireland, together with evidence based individual feedback for any residual errors. This will allow us to internationally address the universal problem of sample mislabeling and WBIT.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Incidence of wrong blood in tube in interns provided with proficiency based progression training supported by technology enhanced learning in 2017 will be compared with historical controls from the same period in 2016
| Arm | Type | Receives |
|---|---|---|
| Proficiently Trained interns - | Active comparator | Behavioral: proficiency based progression trainingProvided with proficiency based progression training supported by technology enhanced learning |
| Historical controls | No intervention | –no extra training provided |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All historical interns blood samples from July to Sept 2016 All interns who receive training and working at Cork University Hospital from July to Sept 2017
Key exclusion criteria (1 listed)
- Interns in 2017 who do not attend for training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| proficiency based progression trainingproficiency based progression training supported by technology enhanced learning | Behavioural | Proficiently Trained interns - |
Primary outcome
WBIT
Time frame: 3 months
Wrong blood in tube
5 secondary outcomes
wrong bottle type
Time frame: 3 months
under filled samples
Time frame: 3 months
clotted samples
Time frame: 3 months
haemolysed samples
Time frame: 3 months
Mislabelling
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Individual participant dataSharing planned: Yes. Available by contacting Principal Investigator
Related trials for Transfusion Related Complication
RecruitingPhase 1
Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO
Cardiogenic Shock, Extracorporeal Membrane Oxygenation
Recruiting
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries- PreTerm
Preterm, Infant Death
RecruitingObservational study
Health-Related Quality-of-Life and Household Financial and Wellbeing Impacts of Prematurity and Necrotising Enterocolitis (NEC).
Prematurity; Extreme, Prematurity; Decision Support
Recruiting
Evaluation of Placental Transfusion Techniques in Prevention of Prematurity Related Complications and Effect on Their Hematological Profile
Premature, Placental Transfusion
RecruitingPhase 1
S-Nitrosylation (SNO) Therapy During Autologous Blood Transfusion
Transfusion Related Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Cahill, MD study chair
UCC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing proficiency based progression training in people with Transfusion Related Complication and Wrong Blood in Tube, run by Patrick Henn at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WBIT (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.