NCT03476005

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

July 5, 2017

Completed
9 months until next milestone

First Posted

Study publicly available on registry

March 23, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2018

Completed
Last Updated

July 5, 2018

Status Verified

July 1, 2018

Enrollment Period

12 months

First QC Date

July 5, 2017

Last Update Submit

July 3, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • WBIT

    Wrong blood in tube

    3 months

Secondary Outcomes (5)

  • wrong bottle type

    3 months

  • under filled samples

    3 months

  • clotted samples

    3 months

  • haemolysed samples

    3 months

  • Mislabelling

    3 months

Study Arms (2)

Proficiently Trained interns -

ACTIVE COMPARATOR

Provided with proficiency based progression training supported by technology enhanced learning

Behavioral: proficiency based progression training

Historical controls

NO INTERVENTION

no extra training provided

Interventions

proficiency based progression training supported by technology enhanced learning

Proficiently Trained interns -

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Interns in 2017 who do not attend for training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CUH

Cork, Ireland

Location

Study Officials

  • Mary Cahill, MD

    UCC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer Medical Education

Study Record Dates

First Submitted

July 5, 2017

First Posted

March 23, 2018

Study Start

July 5, 2017

Primary Completion

July 3, 2018

Study Completion

July 3, 2018

Last Updated

July 5, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will share

Available by contacting Principal Investigator

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
6 months
Access Criteria
Determined by principal investigator

Locations