CClinicalTrials.gg
CompletedNCT03476005Updated Jul 5, 2018

Proficiency Based Training to Investigate WBIT

An interventional study of proficiency based progression training in Transfusion Related Complication and Wrong Blood in Tube, sponsored by Patrick Henn. Completed at 1 site in Ireland. Per ClinicalTrials.gov, last updated 2018-07-05.

Sponsored by Patrick Henn · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
94
Allocation
Non-randomized
Sex
All
01

Study 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. 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.

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.

02

Conditions studied

  • Transfusion Related Complication
  • Wrong Blood in Tube
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Interns in 2017 who do not attend for training

04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
94 participants (actual)

Study arms

  • Active comparator
    Proficiently Trained interns -

    Provided with proficiency based progression training supported by technology enhanced learning

    Behavioral: proficiency based progression training

  • No intervention
    Historical controls

    no extra training provided

Interventions

  • Behavioralproficiency based progression training

    proficiency based progression training supported by technology enhanced learning

05

What researchers measure

Primary outcomes

  1. WBIT

    Wrong blood in tube

    Time frame: 3 months

Secondary outcomes

  1. wrong bottle type

    incorrect bottle type used

    Time frame: 3 months

  2. under filled samples

    number of under filled samples which did not allow analysis

    Time frame: 3 months

  3. clotted samples

    Number of clotted samples

    Time frame: 3 months

  4. haemolysed samples

    number of haemolysed haematology samples

    Time frame: 3 months

  5. Mislabelling

    Mislabelling of forms/bottles in blood bank

    Time frame: 3 months

06

Study locations

1 site
  • CUH
    Cork, Ireland
07

References and documents

Individual participant data

Plan to share: Yes — Available by contacting Principal Investigator

Supporting information: Study protocol, Icf, Csr

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03476005
Lead sponsor
Patrick Henn
Responsible party
Patrick Henn (Lecturer Medical Education, University College Cork) — Sponsor-investigator
First posted
Mar 23, 2018
Start date
Jul 5, 2017
Primary completion
Jul 3, 2018
Completion
Jul 3, 2018
Last update
Jul 5, 2018

Study contacts

Mary Cahill, MD
study chair · UCC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion