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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00115596
Other study ID # CH 05-05-040
Secondary ID
Status Completed
Phase N/A
First received June 23, 2005
Last updated July 18, 2017
Start date June 2005
Est. completion date June 2006

Study information

Verified date July 2017
Source Boston Children’s Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is randomized trial of a procedural skills training curriculum utilizing simulation to teach basic procedural skills to pediatric residents.


Description:

This study is designed to evaluate a formal curriculum for teaching basic procedures to pediatric interns at Children's Hospital, Boston. The incoming class of interns for the academic year '05-06 will be randomly assigned to participate in the curriculum or not. Four procedures including intravenous catheter insertion, venipuncture (blood drawing), bag-and-mask ventilation, and lumbar puncture (spinal tap) will be taught. Interns will then be tested on their ability to perform these skills on anatomic models and on live patients. Our hypothesis is that interns receiving the formal curriculum will be more confident and more successful in performing these procedures than those who do not.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Pediatric Intern in the Boston Combined Residency Program for AY '05-'06

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Formal Curriculum; Low-Fidelity Simulation
The intervention was a formal procedural skills training curriculum consisting of didactic lectures and simulation training.

Locations

Country Name City State
United States Children's Hospital Boston Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Boston Children’s Hospital Association of Pediatric Program Directors

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 1. Percent successful IV placement over 6 months % IVs successfully placed 6/19/2005 - 6/30/2006
Primary 2. Percent successful venipunctures over 6 months % venipunctures with adequate sample for testing 6/19/2005 - 6/30/2006
Primary 3. Score on lumbar puncture subcomponent checklist on simulator at 6 months % steps correct on checklist 6/19/2005 - 6/30/2006
Primary Score on bag mask ventilation 9BMV) subcomponent checklist on simulator at 6 months. % steps correct on checklist 6/19/2005 - 6/30/2006
Secondary Bag Mask Ventilation: 1. Percentage able to successfully ventilate simulator at 0 and 6 months Percentage able to successfully ventilate simulator at 0 and 6 months 6/19/2005 - 6/30/2006
Secondary Average score on BMV checklist at 6 months Average score on subcomponent checklist at 6 months 6/19/2005 - 6/30/2006
Secondary Average time to success at 0 and 6 months Average time to success at 0 and 6 months 6/19/2005 - 6/30/2006
Secondary 4. Score (%) on BMV written test at 0 and 6 months Score (%) on written test at 0 and 6 months 6/19/2005 - 6/30/2006
Secondary 5. Average likert scale scores on confidence with BMV at 6 months Average likert scale scores on confidence with procedures at 6 months 6/19/2005 - 6/30/2006
Secondary IV insertion: 1. Percent successful PIV insertion on simulator at 0 and 6 months Percent successful PIV insertion on simulator at 0 and 6 months 6/19/2005 - 6/30/2006
Secondary Score (%) on PIV subcomponent checklist at 0 and 6 months Score (%) on subcomponent checklist at 0 and 6 months 6/19/2005 - 6/30/2006
Secondary Score (%) on PIV written test at 0 and 6 months Score on written test 6/19/2005 - 6/30/2006
Secondary Average likert scale scores on confidence with PIV at 6 months Likert scale score 6/19/2005 - 6/30/2006
Secondary Venipuncture: 1. Percent successful VP insertion on simulator at 0 and 6 months % VP successul on simulator 6/19/2005 - 6/30/2006
Secondary 2. Score (%) on VP subcomponent checklist at 0 and 6 months Score on checklist 6/19/2005 - 6/30/2006
Secondary 3. Score (%) on VP written test at 0 and 6 months Score on written test 6/19/2005 - 6/30/2006
Secondary 4. Average likert scale scores on confidence with VP at 6 months Likert score 6/19/2005 - 6/30/2006
Secondary Lumbar puncture: 1. Percentage of atraumatic LP attempts over 6 months Successful LPs on patients 6/19/2005 - 6/30/2006
Secondary 2. Score (%) on LP subcomponent checklist on simulator at 6 months Score on checklist 6/19/2005 - 6/30/2006
Secondary 3. Score (%) on subcomponent checklist on first live patient LP checklist score 6/19/2005 - 6/30/2006
Secondary 4. Number of LP attempts needed to demonstrate competence number of LPs 6/19/2005 - 6/30/2006
Secondary 5. Score (%) on LP written test at 0 and 6 months Score on written test 6/19/2005 - 6/30/2006
Secondary 6. Average likert scale scores on confidence with LP at 6 months Likert score 6/19/2005 - 6/30/2006
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