TY - JOUR
T1 - Web-based training and certification of clinical staff during the randomised clinical trial SafeBoosC-III
AU - Rasmussen, Marie Isabel Skov
AU - Hansen, Mathias Lühr
AU - Peters, Colin
AU - Greisen, Gorm
AU - SafeBoosC-III Trial Group
N1 - © 2024. The Author(s).
PY - 2024/10/23
Y1 - 2024/10/23
N2 - BACKGROUND: SafeBoosC-III is a pragmatic, multinational clinical trial evaluating cerebral oximetry-guided treatment for extremely preterm infants. In total, 1601 infants were randomised across 70 sites in Asia, Europe, and USA. To enhance data quality and patient care, a web-based training program was implemented for staff. We now report on the processes.METHODS: All training modules consisted of initial learning material followed by a case-based quiz, with elaborate responses to correct as well as to wrong answers. Modules covered trial introduction, cerebral oximetry monitoring, treatment guidelines, cerebral ultrasound, and Good Clinical Practice. The introduction module was accessible in eight languages on an online platform, while language versions varied for other modules, due to different needs. Certification was earned upon module completion, relevant to the staff category. The training was not mandatory, but for motivational purposes, principal investigators continuously received local certification rate reports.RESULTS: A total of 926 out of 2347 staff (39%) obtained certification. Amongst 295 staff who completed the evaluation, 83% rated the program as overall good and 94% found it relevant to clinical practice. Sites exhibited varying certification rates, with 10 at 0%, 43 between 0.1 and 79.9%, and 17 exceeding 80%. There was no correlation between the rate of certification in individual sites and how often the clinical management was changed due to cerebral hypoxia nor a correlation to site-specific estimates of the intervention effect.CONCLUSION: Despite language barriers and a low budget, our web-based training and certification program proved feasible. Only a minority of sites reached 80% certification of staff and an impact on the trial could not be detected.TRIAL REGISTRATION: The SafeBoosC-III trial is registered at ClinicalTrials.gov NCT03770741. The first participant was randomised in June 2019 and recruitment was completed in December 2021.
AB - BACKGROUND: SafeBoosC-III is a pragmatic, multinational clinical trial evaluating cerebral oximetry-guided treatment for extremely preterm infants. In total, 1601 infants were randomised across 70 sites in Asia, Europe, and USA. To enhance data quality and patient care, a web-based training program was implemented for staff. We now report on the processes.METHODS: All training modules consisted of initial learning material followed by a case-based quiz, with elaborate responses to correct as well as to wrong answers. Modules covered trial introduction, cerebral oximetry monitoring, treatment guidelines, cerebral ultrasound, and Good Clinical Practice. The introduction module was accessible in eight languages on an online platform, while language versions varied for other modules, due to different needs. Certification was earned upon module completion, relevant to the staff category. The training was not mandatory, but for motivational purposes, principal investigators continuously received local certification rate reports.RESULTS: A total of 926 out of 2347 staff (39%) obtained certification. Amongst 295 staff who completed the evaluation, 83% rated the program as overall good and 94% found it relevant to clinical practice. Sites exhibited varying certification rates, with 10 at 0%, 43 between 0.1 and 79.9%, and 17 exceeding 80%. There was no correlation between the rate of certification in individual sites and how often the clinical management was changed due to cerebral hypoxia nor a correlation to site-specific estimates of the intervention effect.CONCLUSION: Despite language barriers and a low budget, our web-based training and certification program proved feasible. Only a minority of sites reached 80% certification of staff and an impact on the trial could not be detected.TRIAL REGISTRATION: The SafeBoosC-III trial is registered at ClinicalTrials.gov NCT03770741. The first participant was randomised in June 2019 and recruitment was completed in December 2021.
KW - Humans
KW - Certification
KW - Oximetry
KW - Infant, Newborn
KW - Infant, Extremely Premature
KW - Health Personnel/education
KW - Inservice Training
KW - Computer-Assisted Instruction/methods
KW - Internet
KW - Cerebrovascular Circulation
KW - Internet-Based Intervention
UR - http://www.scopus.com/inward/record.url?scp=85207411115&partnerID=8YFLogxK
U2 - 10.1186/s13063-024-08530-x
DO - 10.1186/s13063-024-08530-x
M3 - Journal article
C2 - 39444031
SN - 1745-6215
VL - 25
JO - Trials
JF - Trials
IS - 1
M1 - 711
ER -