Proficiency Based Training to Investigate WBIT

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.

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.

Study Overview

• Status: Completed
• Conditions: Transfusion Related Complication; Wrong Blood in Tube
• Intervention / Treatment: Behavioral: proficiency based progression training

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 Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Cork, Ireland
    • CUH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

Interns in 2017 who do not attend for training

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Proficiently Trained interns -; Provided with proficiency based progression training supported by technology enhanced learning	Behavioral: proficiency based progression training; proficiency based progression training supported by technology enhanced learning
No Intervention: Historical controls; no extra training provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WBIT	Wrong blood in tube	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wrong bottle type	incorrect bottle type used	3 months
under filled samples	number of under filled samples which did not allow analysis	3 months
clotted samples	Number of clotted samples	3 months
haemolysed samples	number of haemolysed haematology samples	3 months
Mislabelling	Mislabelling of forms/bottles in blood bank	3 months

Collaborators and Investigators

• Sponsor: Patrick Henn
• Investigators: Study Chair: Mary Cahill, MD, UCC

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2017
• Primary Completion (Actual): July 3, 2018
• Study Completion (Actual): July 3, 2018

Study Registration Dates

• First Submitted: July 5, 2017
• First Submitted That Met QC Criteria: March 17, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): July 5, 2018
• Last Update Submitted That Met QC Criteria: July 3, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: #1710

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Available by contacting Principal Investigator
• IPD Sharing Time Frame: 6 months
• IPD Sharing Access Criteria: Determined by principal investigator
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No