Physicians in Training and Critical Care Nurses Performance in Medical Code Events: Effect of Simulation-Based Training

Ventricular Fibrillation Clinical Trial

Official title:

Physicians in Training and Critical Care Nurses Performance in Medical Code Events: Effect of Simulation-Based Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02707185
• Other study ID #: 10-080
• Secondary ID: MCT STUDY
• Status: Completed
• Phase: N/A
• First received: May 10, 2011
• Last updated: March 11, 2016
• Start date: June 2012
• Est. completion date: December 2014

Study information

• Verified date: March 2016
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

METHODS:

Subjects:

All internal medicine (IM), emergency medicine (EM), anesthesia (A), surgery (S) residents and all hospital ICU nurses (approximately 400 subjects) will be undergoing evaluation and training in CPR techniques according to their department training policy.

Study Assessment Tool:

An objective assessment tool has been developed and tested in medical code scenarios during training sessions recently done in the simulation lab. The tool has five domains: Airway, Breathing, Circulation, Communications/Leadership, and Defibrillation. Each domain consists of 3-8 tasks and skills (attachment A).

Design:

• Phase I: In groups of five to six subjects, residents and nurses will undergo baseline assessment in CPR techniques in the simulation lab. Subject will be presented with a clinical scenario that includes cardiopulmonary arrest. Subjects will be scored by observers based on the previously described assessment tool and will be video recorded.

• Phase II: All study subjects who completed phase I assessment will undergo standardized debriefing and demonstration of proper CPR techniques after reviewing their individual baseline videotape followed by repeated demonstration in CPR techniques during a clinical scenario with cardiopulmonary arrest in the simulation lab. Knowledge retention will be assessed periodically.

• Phase III: Rates of survival to hospital discharge and survival at 24 hours in hospitalized patients after cardiopulmonary arrest collected by the CPR committee and QA department longitudinally for one year after completion of project training (phase II) will be reviewed and compared to the same period one year earlier (CPR outcome data are being collected since 2005 at St. Luke's-Roosevelt Hospitals).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Physicians in training and nurses

Exclusion Criteria:

• Physicians in training and nurses refusing to have their data included in final analysis

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Ventricular Fibrillation

Intervention

Behavioral:
• Simulation-Based Training
An objective assessment tool has been developed and tested in medical code scenarios during training sessions recently done in the simulation lab. The tool has five domains: Airway, Breathing, Circulation, Communications/Leadership, and Defibrillation. Each domain consists of 3-8 tasks and skills.

Locations

Country	Name	City	State
United States	St. Luke's Roosevelt Roosevelt	NYC	New York

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance scale	Change in performance scale at 1 year as compared to baseline	Baseline and 1 year	No
Primary	Rates of survival	Rates of survival to hospital discharge after cardiopulmonary arrest one year after completion of the simulation based training in CPR	1 year	No
Secondary	Survey questionnaire	Change in survey questionnaire score at 1 year as compared to baseline. The questionnaire consists of 4 parts, including: adequacy of training, sense of preparedness, supervision and feedback, and general information. With the exception of the section on general information, responses are scored on a 5 point Likert scale.	Baseline and 1 year	No
Secondary	Perceptions of preparedness	Change in perceptions of preparedness at 1 year as compared to baseline. The method of assessment for this outcome measure is the Likert Scale	Baseline and 1 year	No