Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-03 @ 5:08 PM
Study NCT ID:
NCT03577561
Status:
COMPLETED
Last Update Posted:
2019-07-09
First Post:
2018-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proficiency Based Training to Investigate Blood Sampling Errors Including WBIT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065227', 'term': 'Transfusion Reaction'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018962', 'term': 'Phlebotomy'}], 'ancestors': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '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.\n\nControl 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.\n\nInterventional Group:\n\nThe blood sampling error rate in those doctors in training given the improved proficiency based progression training under investigation from March 30th 2018'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-08', 'studyFirstSubmitDate': '2018-04-30', 'studyFirstSubmitQcDate': '2018-07-03', 'lastUpdatePostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Number of Rejected Samples due to pre-analytical errors', 'timeFrame': '6 months', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Over and Underfilling of the specimen bottle', 'timeFrame': '6 months', 'description': 'Any sample not tested due to over or under filling of the bottle as a percentage of the total number of samples performed'}, {'measure': 'Clotted Samples', 'timeFrame': '6 months', 'description': 'The number of samples not tested due to clotting of the sampleas a percentage of the total number of samples performed'}, {'measure': 'Haemolysed Samples', 'timeFrame': '6 months', 'description': 'The number of blood samples not tested as the blood sample was haemolysedas a percentage of the total number of samples performed'}, {'measure': 'No Specimen Received', 'timeFrame': '6 months', 'description': 'The number of blood requests received without a specimen bottleas a percentage of the total number of samples performed'}, {'measure': 'Incorrect Bottle', 'timeFrame': '6 months', 'description': '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'}, {'measure': 'Other Causes for Rejected Samples', 'timeFrame': '6 months', 'description': 'Any other cause for the blood request not being processed as a percentage of the total number of samples performed'}, {'measure': 'Wrong Blood in Tube', 'timeFrame': '6 months', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Blood Transfusion Complication', 'Wrong Blood in Tube', 'Pre Analytical Blood Sample Errors']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nMETHODS 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.\n\nProficiency 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.\n\nComparison Groups The control groups will be derived from extensive baseline data from CUH hospitals from trainees\n\nControl 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.\n\nControl 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.\n\nData 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.\n\nOnce 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll blood samples performed at Cork Unversity Hospital and Kerry General Hospital by Doctors in Training\n\nExclusion Criteria:\n\nIf 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'}, 'identificationModule': {'nctId': 'NCT03577561', 'briefTitle': 'Proficiency Based Training to Investigate Blood Sampling Errors Including WBIT', 'organization': {'class': 'OTHER', 'fullName': 'University College Cork'}, 'officialTitle': "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?", 'orgStudyIdInfo': {'id': '1820'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group A', 'description': '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.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group B', 'description': '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.', 'interventionNames': ['Other: Proficiency Based Progression Training in Phlebotomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interventional Group', 'description': '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.\n\nThe 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.', 'interventionNames': ['Other: Proficiency Based Progression Training in Phlebotomy']}], 'interventions': [{'name': 'Proficiency Based Progression Training in Phlebotomy', 'type': 'OTHER', 'otherNames': ['Medical Education', 'Simulation Training'], 'description': "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.", 'armGroupLabels': ['Control Group B', 'Interventional Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T12 DC4A', 'city': 'Cork', 'state': 'Munster', 'country': 'Ireland', 'facility': 'Cork University Hospital', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}], 'overallOfficials': [{'name': 'Anthony Gallagher, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University College Cork'}, {'name': 'Mary R Cahill, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College Cork'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '18 months', 'ipdSharing': 'YES', 'description': 'The study data will be made available once the study is completed by contacting the principal investigator', 'accessCriteria': 'At completion of the study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Patrick Henn', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cork University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Patrick Henn', 'investigatorAffiliation': 'University College Cork'}}}}