Proficiency Based Training to Investigate Blood Sampling Errors Including WBIT

Technology Enhanced Learning and Proficiency Based Progression to Investigate and Mitigate Blood Sampling Errors Including 'Wrong Blood in Tube' in Our Hospitals; Can we Improve Patient Safety and Reduce Resource Wastage?

The objective of this study is to determine the effectiveness of a Proficiency Based Progression training programme, together with evidence based individual feedback for any residual errors, which has been specifically developed for healthcare professionals performing phlebotomy at Cork University Hospital at reducing blood sampling errors including Wrong Blood in Tube (WBIT). This will allow us to internationally address the universal problem of sample mislabeling and WBIT. A pilot project which consisted of PBP delivered to 46 interns commencing work in July 2017 has shown a 47% reduction in haematology errors and a 67% reduction in WBITs in the haematology department. However, the sample size was small to result in a statistically significant reduction in WBITs and the investigators are concerned that the results were undermined by the fact that SHOs were not using the method outlined by the metric and may have influenced the standard practice of interns. This study by training interns and SHOs will be better able to determine the influence of the training programme in reducing error rates.

Study Overview

• Status: Completed
• Conditions: Wrong Blood in Tube; Blood Transfusion Complication; Pre Analytical Blood Sample Errors
• Intervention / Treatment: Other: Proficiency Based Progression Training in Phlebotomy

Detailed Description

Objective To determine the effectiveness of a Proficiency Based Progression Training programme, together with evidence based individual feedback for any residual errors, which has been specifically developed for healthcare professionals performing phlebotomy at Cork University Hospital at reducing blood sampling errors including Wrong Blood in Tube (WBIT) .The investigators will use the research data generated to recommend an evidence based training and competency assessment approach to health care providers in Ireland,. This will allow us to internationally address the universal problem of sample mislabeling and WBIT.

METHODS Subjects All SHO (128) and intern (46) trainees working at participating sites during an 18-month timeframe will be asked to participate. For interns the investigators will expect their participation in the two weeks before they commence work in June/July 2018/9. For SHO's the investigators will ensure training is integrated as part of their normal work routine and hospital practices. Participation will be expected and the investigators have secured the backing of the hospital executive management group, clinical directors and university teachers for implementation of this study.

Proficiency based progression training The phlebotomy metric which was developed at CUH in 2017 is the provides the key tool in the development of the PBP training programme. All interns and SHOs in institutions participating in the study will receive PBP training. All trainees will be required to engage with an online didactic education package and a simulation skill training module. Both of these education and training platforms will be derived from the procedure characterisation and benchmarked on experienced practitioner's performance. Trainees will be required to engage with the education and training platforms in a process of deliberate practice learning until they demonstrate the requisite performance benchmark. Only at that point will they be allowed to take samples in a clinical setting. Proficiency demonstration will be mandatory before progressing to ward proctored skill supervision on real patients. In addition, the doctors in training will receive ongoing and proximate feedback on their sampling mislabeling (including wrong blood in tube) performance as soon as it is discovered. Furthermore, they would be responsible for taking the new sample and explain to the patient the accurate reason why the blood sample had to be re-taken, as per open disclosure policy in the HSE.

Comparison Groups The control groups will be derived from extensive baseline data from CUH hospitals from trainees

Control group A: 1 -year historical data (2016/2017) The blood sampling error rate in the interns receiving PBP training in 2018 will be compared to historical data on doctors who would have received whatever training they would normally undergo as a part of their existing training program. It will not differ from what they would normally receive at that institution.

Control group B (2017/2018) In a pilot project in July 2017, 46 interns received the phlebotomy PBP training at CUH. The error rates in the interns in 2017 will be compared to the newly trained interns in 2018 to determine the effectiveness of the training over time.

Data collection at Cork University Hospital The Medically qualified clinical researcher Dr Noirin O'Herlihy, will set up and co-ordinate training for the two medical groups. She will inform the Interns and SHO in formal and informal sessions. She will be present at session to ensure accurate simulation of real life ward environments. She will obtain written informed consent from the medics in simulation and collect baseline demographic data on all doctors in training participating in the study.

Once competency has been demonstrated in simulation, she will be responsible for setting up real life clinical, monitored competency assessment in the real ward setting. Data collection will take place using an agreed standard operating procedure which is closely adhered to by all data collection sites.

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Munster
    • Cork, Munster, Ireland, T12 DC4A
      • Cork University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

All blood samples performed at Cork Unversity Hospital and Kerry General Hospital by Doctors in Training

Exclusion Criteria:

If the doctor is not using his own log in to request blood samples on the clinical manager software If the doctor does not attend the training session

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group A; Control group A: 1 -year historical data (2016/2017) The blood sampling error rate in the interns receiving proficiency based progression training in 2018 will be compared to historical data on doctors who would have received whatever training they would normally undergo as a part of their existing training program. It will not differ from what they would normally receive at that institution.
Active Comparator: Control Group B; Control group B (2017/2018) In a pilot project in July 2017, 46 interns received the phlebotomy proficiency based progression training at CUH. The error rates in the interns in 2017 will be compared to the newly trained interns in 2018 to determine the effectiveness of the training over time. The intervention is the proficiency based progression training programme in phlebotomy.	Other: Proficiency Based Progression Training in Phlebotomy; Trainees will receive an online didactic education package and a simulation skill training module. Both of these education and training platforms will be derived from the procedure characterisation and benchmarked on experienced practitioner's performance. Trainees will be required to engage with the education and training platforms in a process of deliberate practice learning until they demonstrate the requisite performance benchmark. Proficiency demonstration will be mandatory before progressing to ward proctored skill supervision on real patients. In addition, the doctors in training will receive ongoing and proximate feedback on their sampling mislabeling.; Other Names: Medical Education; Simulation Training
Active Comparator: Interventional Group; The blood sampling error rate of doctors in training provided with the intervention i.e. improved proficiency based progression training programme will be analysed from July 10th 2018 until the study ends. The proficiency based progression training will consist of an online eLearning module to teach the doctors the correct process to take blood in the hospital. The doctors will then have to attend a face to face training day on a simulation ward where they will be asked to take blood according to a metric of 77 steps with less than 13 errors and no critical errors. Finally, the doctors will be observed taking blood on the ward and again must take it to a proficient standard.	Other: Proficiency Based Progression Training in Phlebotomy; Trainees will receive an online didactic education package and a simulation skill training module. Both of these education and training platforms will be derived from the procedure characterisation and benchmarked on experienced practitioner's performance. Trainees will be required to engage with the education and training platforms in a process of deliberate practice learning until they demonstrate the requisite performance benchmark. Proficiency demonstration will be mandatory before progressing to ward proctored skill supervision on real patients. In addition, the doctors in training will receive ongoing and proximate feedback on their sampling mislabeling.; Other Names: Medical Education; Simulation Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Rejected Samples due to pre-analytical errors	The total number of blood samples that were not tested due to pre analytical errors by the doctors in training as a percentage of the total number of samples taken by the doctors	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Over and Underfilling of the specimen bottle	Any sample not tested due to over or under filling of the bottle as a percentage of the total number of samples performed	6 months
Clotted Samples	The number of samples not tested due to clotting of the sampleas a percentage of the total number of samples performed	6 months
Haemolysed Samples	The number of blood samples not tested as the blood sample was haemolysedas a percentage of the total number of samples performed	6 months
No Specimen Received	The number of blood requests received without a specimen bottleas a percentage of the total number of samples performed	6 months
Incorrect Bottle	The number of blood requests received where the blood was taken in the incorrect specimen bottle as a percentage of the total number of samples performed	6 months
Other Causes for Rejected Samples	Any other cause for the blood request not being processed as a percentage of the total number of samples performed	6 months
Wrong Blood in Tube	The number of specimens where the blood sample in the tube is not that of the patient label on the specimen bottle as a percentage of the total number of samples performed	6 months

Collaborators and Investigators

• Sponsor: Patrick Henn
• Collaborators: Cork University Hospital
• Investigators: Study Director: Anthony Gallagher, PhD, University College Cork; Principal Investigator: Mary R Cahill, MD, University College Cork

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2018
• Primary Completion (Actual): December 4, 2018
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: April 30, 2018
• First Submitted That Met QC Criteria: July 3, 2018
• First Posted (Actual): July 5, 2018

Study Record Updates

• Last Update Posted (Actual): July 9, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hematologic Diseases; Transfusion Reaction
• Other Study ID Numbers: 1820

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study data will be made available once the study is completed by contacting the principal investigator
• IPD Sharing Time Frame: 18 months
• IPD Sharing Access Criteria: At completion of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; 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