Skip to main content
OpenTrials
Completed

NCT Number: NCT04398602

Leader and Team Performance During PPH Simulated Scenario

The primary aim of this study is the progress of the performance of the leader and of the team for the postpartum hemorrhage (PPH) before and after four high-fidelity standardized scenarios of severe PPH (1500 mL blood loss) due to refractory uterine atony with anesthesia trainees.

Completed

Looking for future studies?

Notify Me

Key information

Age range

25 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eesoa Simulation Center

Roma, 00151, Italy

About this study

8 teams were studied: each team consisted of six participants, all anesthesia trainees, who were given the following roles for the scenario: senior anesthesiologist, anesthesia trainee, obstetrician, midwife, and nurse. The teams encountered the same scenario of a patient with atonic PPH following vaginal delivery. The scenario was repeated four times and the assigned roles to the participants, except that one of the senior anesthesiologists, rotated every each scenario.For the design of the PPH checklist, the authors reviewed PPH guidelines from recognized obstetric bodies (American College of Obstetricians and Gynecologists (ACOG) and the Royal College of Obstetricians and Gynaecologists), relevant papers from the literature and the investigator's institutional PPH protocol. The final action items for the checklist were selected by consensus by all authors. A standardized, 23 key tasks were identified for inclusion on the PPH checklist (non-behavioral skills) and this checklist worked as the reference guide for pre and post-workshop evaluation of the trainees.

For the design of the non-technical skills evaluation scores, the authors reviewed the non-technical skills evaluation instruments, such as the Anaesthetists' Non-Technical Skills (ANTS) behavioural marker system and the Ottawa Global Rating Scale (GRS). The final action items for the checklist were selected by consensus by all authors. Standardized, evaluation and self-evaluation questionnaires were developed .

No educational training was performed before the performance of the first scenario and participants were naïve to the scenario before performing each simulation.

All the teams underwent standardized educational training immediately before the second, third, and fourth scenarios. Every standardized educational training consisted of a 30 minutes session. At the beginning of the session, each participant was invited to write, in three minutes, on a piece of paper, what they would do in case of postpartum bleeding. Afterward each participant was invited to share and to write on the blackboard, one by one, on turn, the clinical procedures that he had previously reported in his personal paper. After this session the instructor, after having asked to all the participant whether there were something else to add, integrated, if necessary, the missing elements by using the 23 key tasks and reconfirmed the agreement with the group itself in order to have a shared check-list of the postpartum hemorrhage treatment.

The scenario consisted of a severe PPH (1500 mL blood loss) due to refractory uterine atony in a multiparous 28-year-old patient who had undergone a spontaneous vaginal delivery. The patient became tachycardic and hypotensive consistent with hemorrhagic shock. All simulations were performed in the simulation room using a high-fidelity mannequin (SinMom Maternal and Neonatal Birthing Simulator, Laerdal, Norway). All simulations were videotaped. The simulation was stopped when each team completed all 23 tasks of the checklist, or when 15 min had elapsed.

A study investigator, expert in both PPH and simulation debriefing, not involved in the simulation, observed each scenario to record and check the team's technical skills according to the established 23 PPH key tasks. The behavioral scores were assigned by two independent observers, experts in communication and evaluation in simulation, who reviewed the videos of each simulation. After each simulation all participants were asked to complete a survey related to the leader and the team behaviors. Questions required a yes/no answer or an answer based on an ordinal scale (1=poor, 5=excellent). Survey questions are presented in the Appendix

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • anesthesia trainee

Exclusion criteria

  • none

Treatment and study plan

behavior of the leader

Behavioral

A study investigator, expert in both PPH and simulation debriefing, not involved in the simulation, observed each scenario to record and check the team's technical skills according to the established 23 PPH key tasks. The behavioral scores were assigned by two independent observers, experts in communication and evaluation in simulation, who reviewed the videos of each simulation each simulation all participants were asked to complete a survey related to the leader and the team behaviors. Questions required a yes/no answer or an answer based on an ordinal scale (1=poor, 5=excellent).

Other names: non technical skills performed by the team

Primary outcomes

  1. leader behavior

    Time frame: 15 minutes

    The behavioral scores (Likert Scale)) were assigned by two independent observers, experts in communication and evaluation in simulation, who reviewed the videos of each simulation.

  2. team performance

    Time frame: 15 minutes

    A study investigator, expert in both PPH and simulation debriefing, not involved in the simulation, observed each scenario to record and check the team's technical skills according to the established 23 PPH key task.

  3. leader self assessment

    Time frame: 15 minutes

    After each simulation all the leaders were asked to complete a survey related to the leader and the team behaviors. Questions required a yes/no answer or an answer based on an ordinal scale (1=poor, 5=excellent).

  4. team self assessment

    Time frame: 15 minutes

    After each simulation all participants were asked to complete a survey related to the leader and the team behaviors. Questions required a yes/no answer or an answer based on an ordinal scale (1=poor, 5=excellent).

Sponsors and collaborators

Lead sponsor

Capogna Giorgio

Other

Registry information

Official study title

Leader and Team Performance During PPH Simulated Scenario: a Comparison Between Self- and Expert's Assessment

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 21, 2020
Registry last updated
May 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.