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Using Emergency Manuals During Interprofessional Crisis Management: Are There Unintended Consequences? (EM)

Primary Purpose

Safety Issues

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emergency Manual (Crisis Checklist)
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Safety Issues focused on measuring Emergency Manual, Crisis Checklist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthcare providers (anesthesiologists, surgeons, nurses) participating in the crisis management curriculum at each participating simulation site

Exclusion Criteria:

  • Those unwilling to be recorded during the simulation scenario

Sites / Locations

  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Emergency Manual

No Emergency

Arm Description

emergency manual present

NO emergency manual present

Outcomes

Primary Outcome Measures

Correct Diagnosis identified during the simulation by the participants through a grading scale tool

Secondary Outcome Measures

Clinical actions taken during the scenario evaluated by a grading scale tool

Full Information

First Posted
December 23, 2016
Last Updated
August 2, 2019
Sponsor
Brigham and Women's Hospital
Collaborators
Anesthesia Patient Safety Foundation, Massachusetts General Hospital, Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03006549
Brief Title
Using Emergency Manuals During Interprofessional Crisis Management: Are There Unintended Consequences?
Acronym
EM
Official Title
Using Emergency Manuals During Interprofessional Crisis Management: Are There Unintended Consequences?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 10, 2015 (Actual)
Primary Completion Date
March 15, 2018 (Actual)
Study Completion Date
May 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Anesthesia Patient Safety Foundation, Massachusetts General Hospital, Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Despite increasing interest in emergency manuals (EMs), relatively little is known about their effectiveness and limitations in the perioperative setting. Prior studies have been limited in that they evaluated EMs using crises that were tailor-made to match one of their chapters, and there has been minimal participation by attending surgeons and other experienced personnel. The Investigators' preliminary experience suggests less-than-expected EM use and suboptimal usage, which may be due to the simulation scenario falling "halfway between" two different chapters of the EM, raising the question of whether limitations were due to the EM content, team dynamics, or inadequate training in the EM use. In this randomized, prospective, two-center simulation-based study, the investigators utilize clinical scenarios specifically designed to observe the patterns of use and to test the limitations of the EMs. The hypothesis is that EMs may not improve, and may even worsen, clinical performance in situations that do not exactly match a specific chapter of that EM, and that EM usage patterns will identify both strengths and limitations of the tools and its implementation. The participating healthcare providers consisting of experienced surgeons, anesthesiologists, and nurses will be randomized into four experimental groups, each exposed to either a "specific" or "non-specific" simulation scenario, along with or without the availability of the EM. The major experimental endpoint will be how many "critical actions" each team performs, scored as the percentage of actions taken from a pre-determined list. The goal of this study is to improve EM content and use by understanding its limitations during interprofessional team-training simulations and to study whether EMs enhance or detract from clinical performance. This is especially a concern in situations that do not exactly match a specific chapter of the EM, such as cases that are vague and represent multi-factorial diagnostic dilemmas such as hypotension and hypoxemia. The ultimate goal is to strengthen patient safety by providing guidance for improving EM content, use, and training protocols.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Safety Issues
Keywords
Emergency Manual, Crisis Checklist

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emergency Manual
Arm Type
Experimental
Arm Description
emergency manual present
Arm Title
No Emergency
Arm Type
No Intervention
Arm Description
NO emergency manual present
Intervention Type
Behavioral
Intervention Name(s)
Emergency Manual (Crisis Checklist)
Intervention Description
participants will have an Emergency Manual available to them during the crisis simulation scenario.
Primary Outcome Measure Information:
Title
Correct Diagnosis identified during the simulation by the participants through a grading scale tool
Time Frame
through scenario completion, an average of 1 hour
Secondary Outcome Measure Information:
Title
Clinical actions taken during the scenario evaluated by a grading scale tool
Time Frame
through scenario completion, an average of 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthcare providers (anesthesiologists, surgeons, nurses) participating in the crisis management curriculum at each participating simulation site Exclusion Criteria: Those unwilling to be recorded during the simulation scenario
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Urman, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02116
Country
United States

12. IPD Sharing Statement

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Using Emergency Manuals During Interprofessional Crisis Management: Are There Unintended Consequences?

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