跳至主要内容
临床试验/NCT03155490
NCT03155490已完成不适用

Translating Simulation-based Team Leadership Training Into Patient-level Outcomes

University of Washington1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2016年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
79
试验地点
1
主要终点
Team leadership

研究概览

简要总结

Brief Summary: Trauma is a major public health burden; it is the fifth most common cause of mortality overall in the US and accounts for the majority of deaths in patients younger than 45. Trauma resuscitations present unique patient care challenges due to the need to perform complex tasks under uncertain and time-pressured conditions. It is not entirely surprising that one-third to one-half of trauma patient-related errors occurred in emergency departments during the initial resuscitation period. Effective team leadership can enhance teamwork and team adaptability, thus improving teams' ability to handle unexpected and rapidly changing situations. Simulation-based training provides a clinically relevant practice environment that has been recommended for team and team leader training.

The purpose of this research is to evaluate the impact of simulation-based leadership training on clinical teamwork, team leadership and patient care. The investigators hypothesize that team leadership training will improve team leadership, teamwork, and critical patient care events during actual trauma resuscitations.

详细描述

Detailed Description: This study will implement an individual randomized controlled trial. Eligible trainee subjects (second or third year emergency medicine or general surgery residents) will be randomized within each month in a 1:1 proportion to either the intervention (team leadership training) or control (no training) conditions. Subjects will be randomized each month to ensure that outcomes are not biased by opportunities for concurrent learning throughout the residency year. The primary outcome is team leadership during actual trauma resuscitations. The secondary outcome is patient care during actual trauma resuscitations. Primary hypotheses include that the intervention group will demonstrate improved leadership (H1) and patient care (H2) during actual trauma resuscitations. The investigators will collect baseline data (pre-intervention, first 2 weeks of the month) and post-intervention/control data (last 2 weeks of the month).

Control Condition: Subjects randomized to the control condition will receive a standard orientation to the trauma team leader role at the start of their month in the ED. This orientation involves review of key administrative information, including departmental policy on chart completion, attendance policy, and available resources. No further formal trauma or team leader training will be provided for the control group.

Intervention Condition: Subjects randomized to the intervention arm of the study will also receive the standard orientation to the trauma leader role at the start of their trauma leader month in the ED. The study coordinator will then schedule these subjects for the leadership training intervention to start 11-13 days after the start of the rotation. Subjects will attend a session where they will complete the demonstration-based training and simulation-based training (simulation + debriefing + additional practice, 4 hours total) curriculum. A Laerdal SimMan 3G patient simulator and trained confederates (team members) will operationalize the resuscitation scenario. The investigators will record all simulations to allow for video-assisted debriefing and opportunity for self-reflection.

Trauma resuscitations will take place at Harborview Medical Center, an urban, tertiary care center affiliated with the University of Washington Medical Center that serves as the sole trauma center for a 5-state region (AK, WA, WY, MT, ID). Dedicated trauma resuscitation bays are equipped for all levels of trauma resuscitations. Data collection during clinical assessments will involve video recording of ongoing trauma resuscitations within two resuscitation bays. All patients presenting to the ED with a trauma-related complaint will be screened using inclusion and exclusion criteria (below). Criteria were chosen to ensure a broad representation of trauma patient care and adequate opportunity to observe team leader behaviors. Certain exclusion criteria (c-g) were selected to try to identify those patients with near 100% mortality or those inappropriate for resuscitative efforts. Additionally, pediatric and pregnant patients will be excluded as their team composition differs markedly from those involved in standard adult trauma resuscitations. Criteria will be further honed and tested prior to data collection to ensure eligible resuscitations are reliably identified and appropriate for the proposed research.

Measures Primary Outcome: Team leadership Trained raters will code video recordings of actual trauma resuscitations using a team leadership rating scale that will produce a single leadership score for each resuscitation. Raters will be blinded to study arm and will have no prior history of interaction with the subject as a physician provider. Leadership rating dimensions will be summed and averaged to create a reliable overall indicator for each trauma case. Aggregation of the multiple trauma case assessments is necessary to both create reliable indicators across trauma cases and to align the level of the data with the unit of observation and the level of analysis (i.e., the subject team leader).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Second or third year emergency medicine or general surgical resident in good standing with the Office of Graduate Medical Education
  • •Up-to-date ATLS-certification
  • •>6 weeks prior experience in trauma care at Harborview Medical Center
  • •Scheduled for a trauma team leader month during the data collection period of the study

排除标准

  • •a) Unavailable for intervention or assessment
  • •****************************************
  • •The trauma patients that are NOT the subjects for this study but who are the clinical recipients of subjects' care also have inclusion/exclusion criteria. These are:
  • •Inclusion Criteria:
  • •Patients with one or more of the following clinical presentations:
  • •i. Witnessed trauma with intubation in the pre-hospital setting ii. Witnessed trauma with hypotensive (SBP< 90 mmHg for two consecutive readings) in the pre-hospital setting iii. Stab wound or impalement to the neck, chest, abdomen, pelvis, or groin iv. MVC with ejection from the vehicle v. Fall > 20ft vi. Pedestrian struck by a motorized vehicle vii. Motorcycle crash > 20 mph viii. Gunshot wounds to the head, neck, chest, abdomen, pelvis, or groin ix. Two or more obvious long bone/ extremity injuries
  • •Exclusion Criteria:
  • •Obstetric patient
  • •Patient status downgraded based on first 5 min. of evaluation
  • •Patient dead on arrival to ED or pronounced dead within 5 min of arrival
  • •Patient removed from ED within 5 minutes of arrival
  • •Patients arriving to the ED with do not resuscitate or comfort care orders
  • •Patients on whom resuscitative efforts ceased within 5 minutes of arrival to the ED

研究组 & 干预措施

Leadership Training

Experimental

Subjects are resident trainees with a role in the emergency department evaluation and management of trauma patients.

干预措施: Leadership training (Behavioral)

Control

No Intervention

Subjects are resident trainees with a role in the emergency department evaluation and management of trauma patients.

结局指标

主要结局

Team leadership

时间窗: Data will be collected pre- and post-intervention for approximately 5 weeks total.

Subject performance during trauma resuscitations is video recorded and assessed using team leadership measure (behaviorally anchored rating scale). Final outcome will be reported as an average score.

次要结局

  • Patient care(Data will be collected pre- and post-intervention for approximately 5 weeks total.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rosemarie Fernandez, MD

Associate Professor, Emergency Medicine

University of Washington

研究点 (1)

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