Clinical trial NCT04278976: Effect of a Competence Based Medical Education Programme on Training Quality in Intensive Care Medicine.
Official title: Effect of a Competence Based Medical Education Programme on Training Quality in Intensive Care Medicine. COBALIDATION TRIAL.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Competency-Based Education
Keywords: Competency-Based Education
Assessment, educational
Simulation training
Patient simulation
Quality assurance, Health care
Intensive Care
Cobatrice
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
Collaborators: name: European Society of Intensive Care Medicine
name: Generalitat Valenciana
First posted: 2020-02-20
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter cluster randomized trial of 14 ICU Department´s from 14 academic referral hospitals located in Spain
Primary purpose: OTHER

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.

Detailed description: Competence Based Medical Education (CBME) stands for a shift in emphasis away from time-based programs, based solely on exposure to experiences such as clinical rotations, in favour of an emphasis on needs-based graduate outcomes authenticity, and learner-centeredness (1). The new paradigm defies the assumption that competence is achieved based on time spent on rotations and instead requires residents to demonstrate competence, what involves performing a significant number of formative assessments (2,3). The CBME model for Intensive Care Medicine (ICM) is called CoBaTrICE (Competency-Based Training in Intensive Care Medicine in Europe) (4), an international partnership of professional organisations and critical care clinicians whose ultimate aims are: to assure a high quality level education in ICM, to harmonize training in ICM without interfering with national specific regulations and to allow for free movement of ICM professionals across Europe (5). CoBaTrICE program used an international grounded approach to defining specialist competencies, and incorporated the views of 1,398 patients and relatives from 70 ICUs in eight EU countries (6). The final program includes 102 competence statements grouped into 12 domains and a definition of the level of expertise required of a safe practitioner at the end of their specialist training. CoBaTrICE has been formally adopted by 15 of 32 countries in Europe with a further 12 planning to do so, Spain is included in this latter group (7,8).

Importance:

CBME is gaining acceptance as a solution to address the challenges associated with the current time-based models of physician training. However, whether CBME programs provide better outcomes than the traditional ones is actually unknown.

Hypothesis:

The implementation of the CoBaTrICE will provide higher levels of competency in comparison with the current official time-based programme in ICM in Spain.

Objectives:

1. To determine the effect of CoBaTrICE implementation on:

   1. The level of competence achieved by the trainees.
   2. The percentage of critical performance elements.
2. To identify gaps in performance that could be addressed in future educational interventions.
3. To investigate the reliability and feasibility of conducting simulation based assessment at multiple sites.
4. To determine compliance with CoBaTrICE and barriers to an effective implementation.

Design:

A multicenter cluster randomized trial of 14 ICU Departments from 14 academic referral hospitals located in Spain. The participating ICUs are general medical and surgical ICUs accredited to train 2-3 new residents in ICM per year.

Participants:

A total of 38 trainees on the 3rd year of the specialization period (R3) will be followed during the three years of their specific training period in ICM (Stage 2). Enrollment will start on February 1, 2019, and the follow-up will end on May 31, 2021.

Intervention: see the specific item in the protocol section.

Main outcomes and measures (see also the specific item in the protocol section):

To determine the level of competency achieved for each participant, a simulation based OSCE (18-26) will be performed at the end of the 3rd year(baseline) and at the end of the 5th year of training in ICM. The OSCE will be performed simultaneously at four simulation centers (Hospital la Fe, Valencia; Francisco de Vitoria, Madrid; IAVANTE, Granada; and Hospital Clinic, Barcelona). Each participant will perform in five 15-min standardized patient or high-fidelity simulated clinical crisis scenarios.

Rating instruments and guide to rating:

Via a Delphi technique, an independent panel of 10 intensivists subject matter experts (simulation instructors and European Diplome in Intensive Care \[EDIC\] examiners) will perform the following tasks: 1) to select the competences to be assessed; 2) to design the scenarios; and 3) to define the items of the checklist for each scenario: a) the critical essential performance elements (CEPE), and b) the critical non-essential performance elements (CNEPE) that must be observed and scored in a yes/no format. CEPEs are defined as essential steps or actions in the management which if missed could have an immediate significant impact on morbidity and mortality. CNEPE are also important for the adequate management of the scenario but they do not have an immediate influence on the outcome. The performances will be video recorded (26). 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 CEPEs and CNEPEs, 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. After each video-assessment, the performance of the trainee will be classified in five levels of competency: Level I: The participant completed less than 60% of the CEPEs. The participant needs guidance and direct supervision to perform the activity in all cases. Level II: The participant completed ≥ 60% of the CEPEs but less than 80% of CEPEs. The participant needs guidance and supervision to perform the activity in most of situations. Level III: The participant completed ≥ 80% of the CEPEs but less than 100% of CEPEs. The participant needs some guidance and supervision to perform the activity in complex situations. Level IV: The participant completed 100% of the CEPEs but less than 80% of CNEPEs. The participant can perform the activity under indirect supervision. Level V: The participant completed 100% of the CEPEs and ≥ 80% of the CEPEs.The participant is independent to perform the activity. Finally, raters also will qualify the performance as: poor, pass, good, outstanding.

Measures will include: 1) the percentage of CEPEs observed; 2) the percentage of CNEPEs observed; 3) the overall competency level achieved on a descriptive scale of 1 to 5 (novice to independent practitioner); 4) the qualitative rating given by the raters based on whether the performance is at the level expected according to the predefined level for the year of training.

Standardization of Scenario Delivery (18-22). In order to facilitate reproducible scenario delivery, rules, detailed scripts and a guidebook for each scenario will be created. The scenario script will describe the elements of the simulated clinical environment (e.g., the equipment and medications available), evolution of the patient's condition throughout the crises and the responses to interventions, standardized answers to anticipated participant questions, and criteria that define successful completion of CPEs. Participants will be briefed on relevant mannequin characteristics, basic rules for participating in simulation scenarios, and location and uses of medications, clinical equipment, and other resources. After finishing the OSCE, resident feedback will be asked through a specific satisfaction survey.

Statistical Analysis:

Sample size: A power analysis has been performed in order to determine the minimum sample size required to detect with a power of .95 (α = .05, 1 - β = .95) a medium effect size (f = .30), requiring a minimum sample size of 90 observations (30 residents).

A mixed factorial ANOVA design will be applied on the time factor (R3-R4-R5) with the group factor (intervention vs. control) for the assessment of professional competences considered, applying post-hoc Bonferroni tests to analyze the principal and interaction effects between the two factors.

In order to estimate the effectiveness of CoBaTrICE, the differences between intervention and control group regarding the primary and secondary end points will be analyzed by a multivariate logistic regression analysis, the adjusted odds ratio will be estimated. Simulation experience defined as participation in at least two crisis resource management courses will be included in the analysis.

Development phases of the study:

The first phase of the project will begin by setting up an independent panel of 10 intensivists experts/executors that will perform the tasks mentioned above. After randomizing the hospitals to the experimental group, the tutors of the this group will be trained through a twelve-hour course integrating: 1) a detailed explanation of the principles, structure, and competencies contemplated in the CoBaTrICE program; 2) the basic principles of the formative assessment, techniques applied, and effective feedback; and 4) the use of the electronic portfolio to record the volume and results of the formative assessments and the progress of the trainee.

At the time of recruitment, residents and tutors of the participant ICUs will complete online several anonymous surveys to explore educational environment, engagement and satisfaction, and professional burnout.

The second phase of the study will consist of the CoBaTrICE program implementation and the comparison of the participating residents' levels of performance through the OSCE at specific points in time, which will be the end of R3 (baseline OSCE) and R5. It will determine: a) whether there are significant differences between the level of competencies shown by the residents depending on the type of training; b) whether there are significant differences in the pace of acquiring the competencies in the two types of programs; and c) the most common errors made by the residents through the different training levels and the possible differences between both programs. The tutors involved in the CoBaTrICE group will receive support to overcome barriers and problems found in the implementation of the program and/or in the use of the tools it incorporates. The tutors will be sent an "ad hoc" questionnaire designed to collect their suggestions. A pilot OSCE with local non-participants residents in the trial will be carried out at the simulation Center In Hospital La Fe, Valencia, Spain, in order to check the feasibility and reliability of the scenarios and the video rating process.The third phase of the study will be devoted to analyzing and publishing the results of the study. Interim analysis will be performed in order to determine the adequate implementation of the program and asses heterogeneity and/or possible bias selection.

Eligibility criteria: 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.

Primary outcomes:
measure: The level of competency achieved at the end of the specific training in ICM (5th year)
timeFrame: Three years
Secondary outcomes:
measure: Percentage of critical performance elements completed in the OSCE.
timeFrame: The two years of CoBaTrICE implementation
measure: The rate of acquisition of competences assessed throughout the two years of CoBaTrICE implementation.
timeFrame: The two years of CoBaTrICE implementation
measure: Compliance with CoBaTrICE implementation in the intervention group
timeFrame: The two years of CoBaTrICE implementation
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Consorci Corporació Sanitária Parc Taulí
state: Barcelona
city: Alicante
country: Spain
facility: Hospital General Universitario, Alicante
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hospital Vall D´Hebron, Barcelona
city: Granada
country: Spain
facility: 4. Hospital Universitario Virgen de Las Nieves de Granada
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrin
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz, Madrid.
city: Murcia
country: Spain
facility: 3. Hospital Clínico Universitario Virgen de La Arrixaca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de La Macarena de Sevilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: 7. Hospital Universitario Doctor Peset de Valencia
Study officials:
affiliation: Instituto de Investigación Sanitaria La Fe de Valencia (IIS La Fe)
name: ALVARO CASTELLANOS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cátedra de psicología de la Educación. Universidad de Valencia
name: RAFAEL GARCIA ROS, PhD
role: STUDY_DIRECTOR
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