Effect of a Competence Based Medical Education Programme on Training Quality in Intensive Care Medicine.

NCT04278976 | Unknown DMC

• 1 other identifier: COBALIDATION
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Competency-Based Education

Keywords

Competency-Based Education; Assessment, educational; Simulation training; Patient simulation; Quality assurance, Health care; Intensive Care; Cobatrice

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percentage of critical performance elements completed in the OSCE.

  The two years of CoBaTrICE implementation

• The rate of acquisition of competences assessed throughout the two years of CoBaTrICE implementation.

  The two years of CoBaTrICE implementation

• Compliance with CoBaTrICE implementation in the intervention group

  The two years of CoBaTrICE implementation

Study Arms (2)

CoBaTriCE

EXPERIMENTAL

Implementation of CoBaTrICE. The implementation of CoBaTrICE is based on: 1. Training the trainers; 2. Multiple Workplace-based assessment exercices; 3. The use of an electronic portfolio.

Other: Implementation of CoBaTrICE

Control

NO INTERVENTION

The participants of the control group will follow the current official model of training in ICM in Spain, which is based on exposure to experiences through time-based clinical rotations; a generic report, non-based on formal assessment, about knowledge, technical and nontechnical skills is performed after every clinical rotation, and yearly by the tutor.

Interventions

Implementation of CoBaTrICE OTHER

The implemention of CoBaTrICE will include the three following essential elements: 1. Training the trainers. In order to provide high quality feedback to guide development of competence, tutors will receive a course in formative assessment, debriefing techniques, and effective feedback. 2. Workplace-based assessment (WbA) to promote learning and to guarantee that the predefined competences and skills are effectively acquired. Current Wb observation methods such as mini-clinical examination exercise, direct observation of procedural skills and multisource-feedback 360º will be used. 3. The use of an electronic portfolio specifically created as a personal collection of training documents that includes the record of formative assessments, activities, and the levels of competence achieved. The portfolio will help monitor progress of trainee's skills development and learning experiences contributing to an effective assessment, self-reflection and control of the learning process.

Also known as: Implementation of a competency-based medical education program

CoBaTriCE

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alvaro Castellanos Ortega: lead
• European Society of Intensive Care Medicine: collaborator
• Generalitat Valenciana: collaborator

Study Sites (14)

Consorci Corporació Sanitária Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital General Universitario, Alicante

Alicante, 03010, Spain

Location

Hospital Universitari Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hospital Vall D´Hebron, Barcelona

Barcelona, 08035, Spain

Location

4. Hospital Universitario Virgen de Las Nieves de Granada

Granada, 18014, Spain

Location

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, 35010, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz, Madrid.

Madrid, 28046, Spain

Location

3. Hospital Clínico Universitario Virgen de La Arrixaca

Murcia, 30120, Spain

Location

Hospital Universitario Virgen de La Macarena de Sevilla

Seville, 41009, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

7. Hospital Universitario Doctor Peset de Valencia

Valencia, 46017, Spain

Location

Related Publications (24)

• 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.

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• 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.

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• Castellanos-Ortega A, Rothen HU, Franco N, Rayo LA, Martin-Loeches I, Ramirez P, Cunat 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.

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• 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. doi: 10.1007/s00134-006-0215-5. Epub 2006 Jul 14.

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• 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. doi: 10.1007/s00134-007-0799-4. Epub 2007 Aug 15.

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• 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.

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• 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.

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• Junta Directiva de la Sociedad Espanola de Medicina Intensiva, Critica 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. Spanish.

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• 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.

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• 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.

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• 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.

  PMID: 23800112 BACKGROUND

• 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.

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• 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. No abstract available.

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• 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.

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• 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. doi: 10.1007/s12630-016-0733-8. Epub 2016 Sep 16.

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• 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.

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  PMID: 36057440 DERIVED

Study Officials

• ALVARO CASTELLANOS, PhD

  Instituto de Investigación Sanitaria La Fe de Valencia (IIS La Fe)

  PRINCIPAL INVESTIGATOR

• RAFAEL GARCIA ROS, PhD

  Cátedra de psicología de la Educación. Universidad de Valencia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: To determine the level of competency achieved for each participant, an Objective Structured Clinical Examination (OSCE) will be performed at the end of the 3rd (R3) and 5th (R5) year of training in ICM. The OSCE will be performed simultaneously at four accredited simulation centers. The performances will be video recorded. All the video recordings will be later rated by two blinded raters, members of the experts panel, using specific checklists which include 25 items with a detailed description of the critical performance elements, the competencies technical (diagnosis and treatment) and non-technical (communication, team leadership, resource management) associated with each item, as well as specific information about what is expected to be done by the trainee. The participants will be unknown to raters. The members of the experts panel will not be part of the staff of the participants ICU Departments.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD. Associated professor of the Universidad de Valencia. Director of the Intensive Care Department of the Hospital Universitario y Politécnico La Fe de Valencia

Model Details: Multicenter cluster randomized trial of 14 ICU Department´s from 14 academic referral hospitals located in Spain

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 20, 2020
• Study Start: February 1, 2019
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (14)