Proficiency Based Training to Investigate Blood Sampling Errors Including WBIT

NCT03577561 | Completed

• 1 other identifier: 1820
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Transfusion Complication; Wrong Blood in Tube; Pre Analytical Blood Sample Errors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Over and Underfilling of the specimen bottle

  6 months

• Clotted Samples

  6 months

• Haemolysed Samples

  6 months

• No Specimen Received

  6 months

• Incorrect Bottle

  6 months

Study Arms (3)

Control group A

NO INTERVENTION

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.

Control Group B

ACTIVE COMPARATOR

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

Interventional Group

ACTIVE COMPARATOR

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

Interventions

Proficiency Based Progression Training in Phlebotomy OTHER

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.

Also known as: Medical Education, Simulation Training

Control Group B; Interventional Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Patrick Henn: lead
• Cork University Hospital: collaborator

Study Sites (1)

Cork University Hospital

Cork, Munster, T12 DC4A, Ireland

Location

MeSH Terms

Conditions

Transfusion Reaction

Interventions

Phlebotomy

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Anthony Gallagher, PhD

  University College Cork

  STUDY DIRECTOR

• Mary R Cahill, MD

  University College Cork

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 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. Interventional Group: The blood sampling error rate in those doctors in training given the improved proficiency based progression training under investigation from March 30th 2018

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: July 5, 2018
• Study Start: July 4, 2018
• Primary Completion: December 4, 2018
• Study Completion: June 30, 2019
• Last Updated: July 9, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 18 months
• Access Criteria: At completion of the study

Locations

IE (1)