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Moderate Sedation Educational Software
This study is ongoing, but not recruiting participants.
Sponsored by: University of Utah
Information provided by: University of Utah
ClinicalTrials.gov Identifier: NCT00708760
  Purpose

We propose to develop and evaluate an interactive education software for administering moderate sedation by non-anesthesiologists.


Condition Intervention
Moderate Sedation Training
Behavioral: paper based training
Behavioral: web based training

U.S. FDA Resources
Study Type: Observational
Study Design: Case-Crossover, Prospective
Official Title: Moderate Sedation Education Software

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • to determine which group - web based or paper based is more effective [ Time Frame: at the end of simulation ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 80
Study Start Date: April 2007
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
2
web based learning group
Behavioral: web based training
read and view selected web based material, test skills learned in simulator lab
1
paper based learning group
Behavioral: paper based training
read selected material, test skills learned in simulator lab

Detailed Description:

The course will be founded upon JCAHO's and ASA's guidelines for sedation, emphasizing the concepts with animations, audio, scenarios, and quizzes. Interactive feedback will be incorporated to guide the clinician during the course. The course will be offered commercially over the World Wide Web, with successful completion providing continuing medical education (CME) credit. It will fulfill JCAHO recommended guidelines. In a controlled simulated environment, the hypothesis that the web based training protocol will provide the practitioner the knowledge base necessary to manage the four scenarios as well or better than practitioners completing the standard moderate sedation certification course will be tested.

1) Evaluate the effectiveness of the course. The University of Utah Center for Patient Simulation is an ideal environment to evaluate the efficacy of a web-based training course. The new web-based course will be compared to standard course material and lessons. We will recruit 40 nurses who administer moderate sedation at the University of Utah Health Sciences Center. Half of the nurses will receive traditional training (typical course and guidelines published from the literature), and half will receive the web-based course. Users will be tested on their knowledge of moderate sedation with four moderate sedation scenarios, in which the simulated patient experiences over-sedation, apnea, and excessive pain.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

nurses providing moderate sedation

Criteria

Inclusion Criteria:

  • general nursing staff at the University of Utah
  • currently required to obtain moderate sedation training
  • an equal basis all clinicians in the respective departments

Exclusion Criteria:

  • nurses and other personnel who do not administer moderate sedation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00708760

Locations
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: James Agutter University of Utah
  More Information

Responsible Party: University of Utah ( James Agutter )
Study ID Numbers: 23011, University of Utah VIP grant
Study First Received: June 30, 2008
Last Updated: January 5, 2009
ClinicalTrials.gov Identifier: NCT00708760  
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
web based learning
moderate sedation

ClinicalTrials.gov processed this record on January 14, 2009