NCT05187299

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

January 10, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

10 days

First QC Date

December 23, 2021

Last Update Submit

December 23, 2021

Conditions

Keywords

educationsimulationobserver toolcardiac arrest

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 minute performance at the end of the session for the procedural test

Secondary Outcomes (3)

  • Q-CPR/Skill Reporter® score

    5 minute performance at the end of the session for the procedural test

  • Global rating of the dyad teamwork score

    5 minute performance at the end of the session for the procedural test

  • knowledge test

    15 minutes for the MCQ test

Study Arms (2)

Group with an observation tool

EXPERIMENTAL

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

Other: observer tool

Group without observation tool

NO INTERVENTION

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

Interventions

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 with an observation tool

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • nd-year medical students

You may not qualify if:

  • unwilling to be assessed
  • absence to the training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Dan BENHAMOU, MD

    Université Paris-Sud

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonia BLANIE, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesia

Study Record Dates

First Submitted

December 23, 2021

First Posted

January 11, 2022

Study Start

January 10, 2022

Primary Completion

January 20, 2022

Study Completion

December 31, 2022

Last Updated

January 11, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share