Competency-Based Education Clinical Trial
— COBALIDATIONOfficial title:
Effect of a Competence Based Medical Education Programme on Training Quality in Intensive Care Medicine. COBALIDATION TRIAL.
Verified date | February 2020 |
Source | Instituto de Investigacion Sanitaria La Fe |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates whether the implementation of a competency-based medical education
program called CoBaTrICE (Competency Based Training program in Intensive Care in Europe)
provides higher levels of competency in comparison with the current official time-based
program in Intensive Care Medicine (ICM) in Spain.
The hypothesis will be confirmed or rejected through a multicenter cluster randomized trial
of 14 ICU Departments from 14 academic referral hospitals located in Spain. A total of 38
trainees on the 3rd year of the specialization period will be followed during the three years
of their specific training period in Intensive Care Medicine. CoBaTrICE (seven hospitals)
will be compared with the current official model of training in ICM in Spain (seven
hospitals), which is based on exposure to experiences through clinical rotations. The
implementation of CoBaTrICE will include the three following essential elements: 1) Training
the trainers; 2) Workplace-based assessments; 3)The use of an electronic portfolio.
The level of competency achieved by each participant will be determined by a simulation-based
Objective Structured Clinical Exam (OSCE) performed at the end of the third year of traning
(baseline) and at the end of the 5th year of training period.
Status | Active, not recruiting |
Enrollment | 38 |
Est. completion date | January 31, 2021 |
Est. primary completion date | January 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Trainees on the 3rd year of the specialization period in Intensive Care Medicine (ICM) who are developing their training program in a Spanish general medical and surgical ICU Department of an academic referral hospital accredited to train 2 or 3 new residents in ICM per year being 3 residents the highest number per year allowed in Spain. Exclusion Criteria: - ICU Departments accredited to train less than 2 new residents in ICM per year - ICU Departments where CoBaTrICE is being implemented. At present only one hospital in Spain (Hospital Universitario y Politécnico La Fe, Valencia) is formally implementing CoBaTrICE. As a consequence it has been excluded from the trial. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital General Universitario, Alicante | Alicante | |
Spain | Hospital Universitari Germans Trias I Pujol | Badalona | |
Spain | Hospital Vall D´Hebron, Barcelona | Barcelona | |
Spain | 4. Hospital Universitario Virgen de Las Nieves de Granada | Granada | |
Spain | Hospital Universitario de Gran Canaria Doctor Negrin | Las Palmas De Gran Canaria | |
Spain | Hospital Clinico San Carlos | Madrid | |
Spain | Hospital Universitario 12 de Octubre | Madrid | |
Spain | Hospital Universitario La Paz, Madrid. | Madrid | |
Spain | 3. Hospital Clínico Universitario Virgen de La Arrixaca | Murcia | |
Spain | Consorci Corporació Sanitária Parc Taulí | Sabadell | Barcelona |
Spain | Hospital Universitario Virgen de La Macarena de Sevilla | Sevilla | |
Spain | Hospital Universitario Virgen Del Rocio | Sevilla | |
Spain | 7. Hospital Universitario Doctor Peset de Valencia | Valencia | |
Spain | Hospital Clínico Universitario de Valencia | Valencia |
Lead Sponsor | Collaborator |
---|---|
Alvaro Castellanos Ortega | European Society of Intensive Care Medicine, Generalitat Valenciana |
Spain,
Bion J, Rothen HU. Models for intensive care training. A European perspective. Am J Respir Crit Care Med. 2014 Feb 1;189(3):256-62. doi: 10.1164/rccm.201311-2058CP. — View Citation
Blum RH, Boulet JR, Cooper JB, Muret-Wagstaff SL; Harvard Assessment of Anesthesia Resident Performance Research Group. Simulation-based assessment to identify critical gaps in safe anesthesia resident performance. Anesthesiology. 2014 Jan;120(1):129-41. doi: 10.1097/ALN.0000000000000055. — View Citation
Carraccio C, Englander R, Van Melle E, Ten Cate O, Lockyer J, Chan MK, Frank JR, Snell LS; International Competency-Based Medical Education Collaborators. Advancing Competency-Based Medical Education: A Charter for Clinician-Educators. Acad Med. 2016 May;91(5):645-9. doi: 10.1097/ACM.0000000000001048. — View Citation
Castellanos-Ortega A, Rothen HU, Franco N, Rayo LA, Martín-Loeches I, Ramírez P, Cuñat de la Hoz J. Training in intensive care medicine. A challenge within reach. Med Intensiva. 2014 Jun-Jul;38(5):305-10. doi: 10.1016/j.medin.2013.12.011. Epub 2014 Mar 1. English, Spanish. — View Citation
Chiu M, Tarshis J, Antoniou A, Bosma TL, Burjorjee JE, Cowie N, Crooks S, Doyle K, Dubois D, Everett T, Fisher R, Hayter M, McKinnon G, Noseworthy D, O'Regan N, Peachey G, Robitaille A, Sullivan M, Tenenbein M, Tremblay MH. Simulation-based assessment of anesthesiology residents' competence: development and implementation of the Canadian National Anesthesiology Simulation Curriculum (CanNASC). Can J Anaesth. 2016 Dec;63(12):1357-1363. Epub 2016 Sep 16. — View Citation
CoBaTrICE Collaboration, Bion JF, Barrett H. Development of core competencies for an international training programme in intensive care medicine. Intensive Care Med. 2006 Sep;32(9):1371-83. Epub 2006 Jul 14. — View Citation
CoBaTrICE Collaboration. The views of patients and relatives of what makes a good intensivist: a European survey. Intensive Care Med. 2007 Nov;33(11):1913-20. Epub 2007 Aug 15. — View Citation
Dougherty P, Ross PT, Lypson ML. Monitoring resident progress through mentored portfolios. J Grad Med Educ. 2013 Dec;5(4):701-2. doi: 10.4300/JGME-D-13-00309.1. — View Citation
Easdown LJ, Wakefield ML, Shotwell MS, Sandison MR. A Checklist to Help Faculty Assess ACGME Milestones in a Video-Recorded OSCE. J Grad Med Educ. 2017 Oct;9(5):605-610. doi: 10.4300/JGME-D-17-00112.1. — View Citation
Everett TC, Ng E, Power D, Marsh C, Tolchard S, Shadrina A, Bould MD. The Managing Emergencies in Paediatric Anaesthesia global rating scale is a reliable tool for simulation-based assessment in pediatric anesthesia crisis management. Paediatr Anaesth. 2013 Dec;23(12):1117-23. doi: 10.1111/pan.12212. Epub 2013 Jun 26. — View Citation
Frank JR, Snell L, Englander R, Holmboe ES; ICBME Collaborators. Implementing competency-based medical education: Moving forward. Med Teach. 2017 Jun;39(6):568-573. doi: 10.1080/0142159X.2017.1315069. — View Citation
Fung L, Boet S, Bould MD, Qosa H, Perrier L, Tricco A, Tavares W, Reeves S. Impact of crisis resource management simulation-based training for interprofessional and interdisciplinary teams: A systematic review. J Interprof Care. 2015;29(5):433-44. doi: 10.3109/13561820.2015.1017555. Epub 2015 May 14. Review. — View Citation
Gruppen L, Frank JR, Lockyer J, Ross S, Bould MD, Harris P, Bhanji F, Hodges BD, Snell L, Ten Cate O; ICBME Collaborators. Toward a research agenda for competency-based medical education. Med Teach. 2017 Jun;39(6):623-630. doi: 10.1080/0142159X.2017.1315065. — View Citation
Hastie MJ, Spellman JL, Pagano PP, Hastie J, Egan BJ. Designing and implementing the objective structured clinical examination in anesthesiology. Anesthesiology. 2014 Jan;120(1):196-203. doi: 10.1097/ALN.0000000000000068. Review. — View Citation
Heeneman S, Driessen EW. The use of a portfolio in postgraduate medical education - reflect, assess and account, one for each or all in one? GMS J Med Educ. 2017 Nov 15;34(5):Doc57. doi: 10.3205/zma001134. eCollection 2017. — View Citation
Ilgen JS, Ma IW, Hatala R, Cook DA. A systematic review of validity evidence for checklists versus global rating scales in simulation-based assessment. Med Educ. 2015 Feb;49(2):161-73. doi: 10.1111/medu.12621. Review. — View Citation
Junta Directiva de la Sociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias (SEMICYUC). [Intensive medicine in Spain]. Med Intensiva. 2011 Mar;35(2):92-101. doi: 10.1016/j.medin.2010.12.008. Epub 2011 Mar 2. Review. Spanish. — View Citation
Khanduja PK, Bould MD, Naik VN, Hladkowicz E, Boet S. The role of simulation in continuing medical education for acute care physicians: a systematic review. Crit Care Med. 2015 Jan;43(1):186-93. doi: 10.1097/CCM.0000000000000672. Review. — View Citation
Lee V, Brain K, Martin J. Factors Influencing Mini-CEX Rater Judgments and Their Practical Implications: A Systematic Literature Review. Acad Med. 2017 Jun;92(6):880-887. doi: 10.1097/ACM.0000000000001537. Review. — View Citation
Lockyer J, Carraccio C, Chan MK, Hart D, Smee S, Touchie C, Holmboe ES, Frank JR; ICBME Collaborators. Core principles of assessment in competency-based medical education. Med Teach. 2017 Jun;39(6):609-616. doi: 10.1080/0142159X.2017.1315082. — View Citation
McIvor WR, Banerjee A, Boulet JR, Bekhuis T, Tseytlin E, Torsher L, DeMaria S Jr, Rask JP, Shotwell MS, Burden A, Cooper JB, Gaba DM, Levine A, Park C, Sinz E, Steadman RH, Weinger MB. A Taxonomy of Delivery and Documentation Deviations During Delivery of High-Fidelity Simulations. Simul Healthc. 2017 Feb;12(1):1-8. doi: 10.1097/SIH.0000000000000184. — View Citation
Seam N, Lee AJ, Vennero M, Emlet L. Simulation Training in the ICU. Chest. 2019 Dec;156(6):1223-1233. doi: 10.1016/j.chest.2019.07.011. Epub 2019 Jul 30. Review. — View Citation
Weinger MB, Banerjee A, Burden AR, McIvor WR, Boulet J, Cooper JB, Steadman R, Shotwell MS, Slagle JM, DeMaria S Jr, Torsher L, Sinz E, Levine AI, Rask J, Davis F, Park C, Gaba DM. Simulation-based Assessment of the Management of Critical Events by Board-certified Anesthesiologists. Anesthesiology. 2017 Sep;127(3):475-489. doi: 10.1097/ALN.0000000000001739. — View Citation
* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The level of competency achieved at the end of the specific training in ICM (5th year) | The percentage of competences assessed through an Objective Structured Clinical Examination (OSCE) in which level 5 (independent practitioner) was achieved | Three years | |
Secondary | Percentage of critical performance elements completed in the OSCE. | Percentage of critical essential performance elements and percentage of critical non-essential performance elements completed in the OSCE. | The two years of CoBaTrICE implementation | |
Secondary | The rate of acquisition of competences assessed throughout the two years of CoBaTrICE implementation. | The number of competences achieved at the end of the 5th year in comparison to the competences showed in the baseline OSCE | The two years of CoBaTrICE implementation | |
Secondary | Compliance with CoBaTrICE implementation in the intervention group | Percentage of CoBaTrICE competences assessed throughout the last two-years specific stage of training in ICM | The two years of CoBaTrICE implementation |
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