- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01548547
Patient Outcomes in Simulation Education (POISE) Intravenous (IV) and Lumbar Puncture (LP) Multi-institution Protocol (POISE)
April 18, 2024 updated by: Columbia University
This study aims to compare the clinical efficacy of multimedia audiovisual training to hands on "practice till perfect" training for pediatric and emergency medicine residents' procedural skills.
This initial study will explore the success rates on infant lumbar puncture and child intravenous access skills in post-graduate year one pediatric residents.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
210
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Pediatric interns at POISE network hospitals
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: LP mastery learning group
|
Hands-on coached deliberate practice on a simulator.
Training until mastery achieved.
|
|
Active Comparator: IV mastery learning group
|
Hands-on coached deliberate practice on a simulator.
Training until mastery achieved.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of clinical success with lumbar puncture (LP) procedures
Time Frame: Up to one year
|
Online performance form
|
Up to one year
|
|
Rate of clinical success with intravenous (IV) procedures
Time Frame: Up to one year
|
Online performance form
|
Up to one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Kessler, MD, MSc, Columbia University
- Study Director: Martin Pusic, MD, PhD, Columbia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
March 5, 2012
First Submitted That Met QC Criteria
March 7, 2012
First Posted (Estimated)
March 8, 2012
Study Record Updates
Last Update Posted (Actual)
April 19, 2024
Last Update Submitted That Met QC Criteria
April 18, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAE0924
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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