NCT03155490

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

October 18, 2018

Status Verified

October 1, 2018

Enrollment Period

1.7 years

First QC Date

May 11, 2017

Last Update Submit

October 16, 2018

Conditions

Keywords

Hospital medical emergency teamLeadershipSimulation training

Outcome Measures

Primary Outcomes (1)

  • Team leadership

    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.

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

Secondary Outcomes (1)

  • Patient care

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

Other Outcomes (3)

  • Survival to discharge

    Data will be collected up to 4 months after admission

  • Total hospital length of stay

    Data will be collected up to 4 months after admission

  • Total intensive care length of stay

    Data will be collected up to 4 months after admission

Study Arms (2)

Leadership Training

EXPERIMENTAL

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

Behavioral: Leadership training

Control

NO INTERVENTION

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

Interventions

Subjects randomized to the experimental arm of the study will receive an additional 4 hours of simulation-based trauma team leadership training. This training is in addition to the baseline 2 hours of trauma leader training and orientation all subjects receive.

Leadership Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • a) Unavailable for intervention or assessment
  • \*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*
  • Age \> 21
  • 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
  • Prisoners
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Rosemarie Fernandez, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Emergency Medicine

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 16, 2017

Study Start

April 1, 2016

Primary Completion

December 1, 2017

Study Completion

August 1, 2018

Last Updated

October 18, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations