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Use of an Observer Tool to Improve Learning Outcomes for Cardiac Arrest Management

Primary Purpose

Simulation, Education

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
observer tool
Sponsored by
Université Paris-Sud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Simulation focused on measuring education, simulation, observer tool, cardiac arrest

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 2nd-year medical students

Exclusion Criteria:

  • unwilling to be assessed
  • absence to the training

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Group with an observation tool

    Group without observation tool

    Arm Description

    In this group (OT +), each student will complete an observer tool each time another dyad is performing

    In this group (OT-), the student will not use the observer tool and will observe other students without any physical support.

    Outcomes

    Primary Outcome Measures

    global score
    The primary outcome will be a global score describing acquisition of the skills immediately after training by comparing the groups using or not the OT (level 1-2 of the Kirkpatrick model). This score will be the sum of adequately performed items (yes/no) of the checklist which forms the observer tool itself. Although this checklist has not been validated previously, it has been constructed by experts in education, intensive care and simulation who are well aware of the constraints which are associated with such an assessment method. In addition, checklists are a usual mode of evaluation on procedural simulation. The total score is a 25 point-checklist which describes the overall performance of the dyad. Each student will also be assessed separately and points related to his (her) specific action will be counted.

    Secondary Outcome Measures

    Q-CPR/Skill Reporter® score
    The Q-CPR Laerdal ® mannequin equipped with the wireless Skill reporter® software) displays on a screen the main parameters (i.e. frequency, depth of massage, hand position and rib relaxation) and calculates an overall score which includes also the number of compressions per minute. Criteria of the compression score are taken up by the ERC 2015 recommendations in the definition of "High quality CPR". This global score has been used in previous published studies to evaluate the overall performance during cardiac massage. Individual components of the score are also provided by the software.
    Global rating of the dyad teamwork score
    Simplified Anaesthetist' Non-Technical Skills scale
    knowledge test
    Multiple choice questionnaire

    Full Information

    First Posted
    December 23, 2021
    Last Updated
    December 23, 2021
    Sponsor
    Université Paris-Sud
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05187299
    Brief Title
    Use of an Observer Tool to Improve Learning Outcomes for Cardiac Arrest Management
    Official Title
    Does the Use of an Observer Tool During Simulation Training Improves Learning Outcomes for Cardiac Arrest Management: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 10, 2022 (Anticipated)
    Primary Completion Date
    January 20, 2022 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Université Paris-Sud

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Only approximately 10.4% of patients with out-of-hospital cardiac arrest (OHCA) survive their initial hospitalization. The very early management of cardiac arrest is indeed considered an extremely important criterion to improve patients' outcome. Despite recent advances and improved results, outcomes remain poor, especially because bystanders are not well trained to manage such a crisis situation. According to the International Liaison Committee on Resuscitation, teaching and learning the knowledge, skills and attitudes of resuscitation with the ultimate aim of improving patient survival after cardiac arrest is thus an essential goal. Teaching and learning strategies are numerous and have been well described and reviewed recently. Considering initial training methods already requires attention as study results often fail to show complete and effective learning after the initial training. Educational efficiency may be improved by several means (for example use of digital media) but it is now clear that more effective training strategies, i.e. those focusing on the cognitive process which leads to inclusion in memory), are needed. One recently introduced strategy, mainly in the field of simulation, is the use of observer tools. It has been shown that although effectiveness was still poorly demonstrated, this method had the potential to improve learning outcomes. An observer tool is a document which is used by observers during a scenario played by other learners and immediately compares the player's technical or non-technical skills with a referential guide. As it has been shown that observers learn less than those on the "hot seat" and as time for training is limited and the number of trainees is huge, focusing on observers is important. By visually assessing the practice of others repeatedly during the course and comparing each performance to the reference (i.e. the observer tool), the learner may increase his engagement in the training process with an expected final result of improved training efficacy. In a previous study performed in our simulation center, it has been have shown that using an observer tool increases immediate learning scores during operating room crisis management simulation. Good data on the use of such an observer tool in other training fields is needed to confirm these preliminary positive results.
    Detailed Description
    Outcomes of cardiac arrest remain poor (1). The International Liaison Committee on Resuscitation (ILCOR) emphasizes that one essential component for good resuscitation outcomes is effective education of the lay public and resuscitation providers (2). Even when modern learning methods (i.e. for example digital aids) are used, the final result at the end of initial training can be described as providing incomplete knowledge and performance. During training sessions, it is often seen that the time during which the learners really act is short and they are positioned in a role of observer for a variable duration (but often a long proportion of the course duration). As it has been shown that observers learn less than those on the "hot seat" (3) and as time for training is limited and the number of trainees is huge, focusing on observers is important to increase the overall level of knowledge. To increase the positive effects of the simulation when the learner is in the role of observer, some authors have proposed to strengthen the educational effect through the use of an observer tool that observers must complete by analyzing the progress of the task performed by their colleagues (4). This is a list describing the set of key points to be achieved. However, data concerning the educational value of these observer tools are limited. Studies on the use of these tools during crisis management training in the operating room assessed by high-fidelity simulation have been already conducted (5) but good data on the use of such an observer tool in other training fields is needed to confirm these preliminary positive results. The objective of this study will be to assess the value of using an observer tool (OT) (including mainly the key points of technical performance) to improve learning outcomes of medical students during cardiac arrest training involving simulation. For medical students, learning how to manage a cardiac arrest is taught early in their curriculum, at a stage where their medical knowledge is low, and their overall competence is close to a layperson. This means that improving medical students' learning outcomes may also be a reasonable mean to improve training methods of non-medical personnel. This prospective and randomized study will be performed in the Paris-Saclay University (LabForSIMS) simulation center. The study will be carried out with the use of the CONSORT tool adapted for simulation studies and the GREET Tool for educational studies (6). Students will be in the first part of the 2nd year of their curriculum, explaining why only basic life support is taught at this stage. The training session lasts the whole day and 20-30 students are trained each day. Sessions are mainly focused on cardiac arrest management but a third of the day is dedicated to learning other resuscitation techniques (management of limb hemorrhage, Heimlich maneuver, recovery position for an unconscious patient who maintains spontaneous breathing…). The cardiac arrest part of the workshop is divided into five portions (diagnosis of unconsciousness, call for help/emergency services, diagnosis of apnea, external cardiac massage and use of an automated defibrillator). At each stage, two students are encouraged to make a spontaneous preliminary performance followed by other students' and teacher's comments and explanations. Students are then invited to perform by themselves the scenario, with progressive increments at each of the five additional portions. In practical terms, students working in dyads, perform initially the procedure which leads to diagnosis of unconsciousness but at the end of the session, they perform the whole five steps described above. When students are not players, they observe the dyad and are encouraged to analyze what has been well done and what could have better performed. Cardiac massage training is facilitated by the use of a feed-back device (Q-CPR Laerdal ® mannequin equipped with the wireless Skill reporter®software) which displays on a screen the main parameters (i.e. frequency, depth of massage, hand position, rib relaxation), allowing trainees to assess and improve immediately their performance. In the present study, after informed consent, students will be randomized in to groups: Group with an observation tool (OT +) filled out at each time the students are not on the hot seat. The observer tool is paper-based and is divided in columns (each column filled out for a dyad observed) with lines representing the above-described steps of learning and presented with visual incremental actions to be performed. The observer tool will only be used to reinforce learning and will not be used for summative evaluation. Instructors have already been involved in previous simulation studies performed in our center, and especially those in which an observer tool has been assessed (one study published, two manuscripts in preparation). Group without observation tool (OT-): these students will be trained as usual, i.e. will be encouraged to express their thoughts after each dyad has finished but will not be given the observer tool. The randomization will be performed by day as it is not possible to randomize students themselves on a given day for practical reasons. At the end of the training day, all learners will be again invited to perform a complete cardiac arrest management (basic life support part), using the previously described mannequin with feed-back information. During this ultimate performance, students will not be allowed to see the screen and will not know if they perform adequately. The overall score automatically provided by the Q-CPR/Skill Reporter® system will only be available to the assessor and the result provided to the student at the end of the test with a short feed-back from the instructor. A 10 question MCQ test will also be applied at the end of the session. This MCQ will be prepared by the instructors who had prepared the checklist to highlight important theoretical knowledge on cardiac arrest management.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Simulation, Education
    Keywords
    education, simulation, observer tool, cardiac arrest

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group with an observation tool
    Arm Type
    Experimental
    Arm Description
    In this group (OT +), each student will complete an observer tool each time another dyad is performing
    Arm Title
    Group without observation tool
    Arm Type
    No Intervention
    Arm Description
    In this group (OT-), the student will not use the observer tool and will observe other students without any physical support.
    Intervention Type
    Other
    Intervention Name(s)
    observer tool
    Intervention Description
    The observer tool is paper-based and is divided in columns (each column filled out for a dyad observed) with lines representing the above-described steps of learning and presented with visual incremental actions to be performed. The observer tool will only be used to reinforce learning and will not be used for summative evaluation. Instructors have already been involved in previous simulation studies performed in our center, and especially those in which an observer tool has been assessed (one study published, two manuscripts in preparation).
    Primary Outcome Measure Information:
    Title
    global score
    Description
    The primary outcome will be a global score describing acquisition of the skills immediately after training by comparing the groups using or not the OT (level 1-2 of the Kirkpatrick model). This score will be the sum of adequately performed items (yes/no) of the checklist which forms the observer tool itself. Although this checklist has not been validated previously, it has been constructed by experts in education, intensive care and simulation who are well aware of the constraints which are associated with such an assessment method. In addition, checklists are a usual mode of evaluation on procedural simulation. The total score is a 25 point-checklist which describes the overall performance of the dyad. Each student will also be assessed separately and points related to his (her) specific action will be counted.
    Time Frame
    5 minute performance at the end of the session for the procedural test
    Secondary Outcome Measure Information:
    Title
    Q-CPR/Skill Reporter® score
    Description
    The Q-CPR Laerdal ® mannequin equipped with the wireless Skill reporter® software) displays on a screen the main parameters (i.e. frequency, depth of massage, hand position and rib relaxation) and calculates an overall score which includes also the number of compressions per minute. Criteria of the compression score are taken up by the ERC 2015 recommendations in the definition of "High quality CPR". This global score has been used in previous published studies to evaluate the overall performance during cardiac massage. Individual components of the score are also provided by the software.
    Time Frame
    5 minute performance at the end of the session for the procedural test
    Title
    Global rating of the dyad teamwork score
    Description
    Simplified Anaesthetist' Non-Technical Skills scale
    Time Frame
    5 minute performance at the end of the session for the procedural test
    Title
    knowledge test
    Description
    Multiple choice questionnaire
    Time Frame
    15 minutes for the MCQ test

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 2nd-year medical students Exclusion Criteria: unwilling to be assessed absence to the training
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dan BENHAMOU, MD
    Phone
    33 1 45 21 34 41
    Email
    dan.benhamou@aphp.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Antonia BLANIE, MD, PhD
    Phone
    33 1 45 21 34 41
    Email
    antonia.blanie@aphp.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dan BENHAMOU, MD
    Organizational Affiliation
    Université Paris-Sud
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33081529
    Citation
    Panchal AR, Bartos JA, Cabanas JG, Donnino MW, Drennan IR, Hirsch KG, Kudenchuk PJ, Kurz MC, Lavonas EJ, Morley PT, O'Neil BJ, Peberdy MA, Rittenberger JC, Rodriguez AJ, Sawyer KN, Berg KM; Adult Basic and Advanced Life Support Writing Group. Part 3: Adult Basic and Advanced Life Support: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2020 Oct 20;142(16_suppl_2):S366-S468. doi: 10.1161/CIR.0000000000000916. Epub 2020 Oct 21. No abstract available.
    Results Reference
    result
    PubMed Identifier
    33773831
    Citation
    Greif R, Lockey A, Breckwoldt J, Carmona F, Conaghan P, Kuzovlev A, Pflanzl-Knizacek L, Sari F, Shammet S, Scapigliati A, Turner N, Yeung J, Monsieurs KG. European Resuscitation Council Guidelines 2021: Education for resuscitation. Resuscitation. 2021 Apr;161:388-407. doi: 10.1016/j.resuscitation.2021.02.016. Epub 2021 Mar 24.
    Results Reference
    result
    PubMed Identifier
    34120134
    Citation
    Suet G, Blanie A, De Montblanc J, Benhamou D. Use of an Observer Tool to Enhance Observers' Learning of Anesthesia Residents During High-Fidelity Simulation: A Randomized Controlled Trial. Simul Healthc. 2022 Feb 1;17(1):e75-e82. doi: 10.1097/SIH.0000000000000584.
    Results Reference
    result
    PubMed Identifier
    12697584
    Citation
    Fletcher G, Flin R, McGeorge P, Glavin R, Maran N, Patey R. Anaesthetists' Non-Technical Skills (ANTS): evaluation of a behavioural marker system. Br J Anaesth. 2003 May;90(5):580-8. doi: 10.1093/bja/aeg112.
    Results Reference
    result

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    Use of an Observer Tool to Improve Learning Outcomes for Cardiac Arrest Management

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