Blood Transfusion ComplicationNCT03577561
Proficiency Based Training to Investigate Blood Sampling Errors Including WBIT
A study testing Proficiency Based Progression Training in Phlebotomy in people with Blood Transfusion Complication and Wrong Blood in Tube, run by Patrick Henn at 1 site in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Blood Transfusion Complication, Wrong Blood in Tube, Pre Analytical Blood Sample Errors
- What is being tested?
- Proficiency Based Progression Training in Phlebotomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteIreland
- Study dates
- 4 Jul 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All blood samples performed at Cork Unversity Hospital and Kerry General Hospital by Doctors in Training
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Proficiency Based Progression Training in Phlebotomy
- Medical subject headings
- Transfusion Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proficiency Based Progression Training in PhlebotomyOther
Also called Medical Education, Simulation Training
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Proficiency Based Progression Training in Phlebotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 6 months
No Specimen Received
The number of blood requests received without a specimen bottleas a percentage of the total number of samples performed
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start4 Jul 2018
- Primary completion4 Dec 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Transfusion ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patrick Henn
- Sponsor type
- University, hospital or other
- Collaborators
- Cork University Hospital
- Responsible party
- Sponsor-investigator, Patrick Henn, University College Cork
- Investigators
- Anthony Gallagher, PhD, Study director, University College CorkMary R Cahill, MD, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577561
- Sponsor's protocol ID
- 1820
- Status last verified
- Jul 2019
- First submitted
- 30 Apr 2018
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study data will be made available once the study is completed by contacting the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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?
- ClinicalTrials.gov ID
- NCT03577561
- Acronym / sponsor ID
- 1820
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Patrick HennUniversity, hospital or other
- Collaborators
- Cork University Hospital
- Study start
- 4 Jul 2018 (actual)
- Primary completion
- 4 Dec 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 5 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Proficiency Based Progression Training in PhlebotomyControl 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. |
| Interventional Group | Active comparator | Other: Proficiency Based Progression Training in PhlebotomyThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All blood samples performed at Cork Unversity Hospital and Kerry General Hospital by Doctors in Training
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proficiency Based Progression Training in PhlebotomyAlso: Medical Education, Simulation TrainingTrainees 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 | Control Group B, Interventional Group |
Primary outcome
Total Number of Rejected Samples due to pre-analytical errors
Time frame: 6 months
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
7 secondary outcomes
Over and Underfilling of the specimen bottle
Time frame: 6 months
Clotted Samples
Time frame: 6 months
Haemolysed Samples
Time frame: 6 months
No Specimen Received
Time frame: 6 months
Incorrect Bottle
Time frame: 6 months
Other Causes for Rejected Samples
Time frame: 6 months
Wrong Blood in Tube
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Individual participant dataSharing planned: Yes. The study data will be made available once the study is completed by contacting the principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Gallagher, PhD study director
University College Cork
Mary R Cahill, MD principal investigator
University College Cork
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proficiency Based Progression Training in Phlebotomy in people with Blood Transfusion Complication and Wrong Blood in Tube, run by Patrick Henn at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Rejected Samples due to pre-analytical errors (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.