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Reforming Pediatric Procedural Training

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00115596
First Posted: June 24, 2005
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Association of Pediatric Program Directors
Information provided by (Responsible Party):
Michael Gaies, Boston Children's Hospital
  Purpose
This study is randomized trial of a procedural skills training curriculum utilizing simulation to teach basic procedural skills to pediatric residents.

Condition Intervention
Health Personnel Healthy Other: Formal Curriculum; Low-Fidelity Simulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Reforming Pediatric Procedural Training: Developing an Evidence-Based Curriculum

Further study details as provided by Michael Gaies, Boston Children's Hospital:

Primary Outcome Measures:
  • 1. Percent successful IV placement over 6 months [ Time Frame: 6/19/2005 - 6/30/2006 ]
    % IVs successfully placed

  • 2. Percent successful venipunctures over 6 months [ Time Frame: 6/19/2005 - 6/30/2006 ]
    % venipunctures with adequate sample for testing

  • 3. Score on lumbar puncture subcomponent checklist on simulator at 6 months [ Time Frame: 6/19/2005 - 6/30/2006 ]
    % steps correct on checklist

  • Score on bag mask ventilation 9BMV) subcomponent checklist on simulator at 6 months. [ Time Frame: 6/19/2005 - 6/30/2006 ]
    % steps correct on checklist


Secondary Outcome Measures:
  • Bag Mask Ventilation: 1. Percentage able to successfully ventilate simulator at 0 and 6 months [ Time Frame: 6/19/2005 - 6/30/2006 ]
    Percentage able to successfully ventilate simulator at 0 and 6 months

  • Average score on BMV checklist at 6 months [ Time Frame: 6/19/2005 - 6/30/2006 ]
    Average score on subcomponent checklist at 6 months

  • Average time to success at 0 and 6 months [ Time Frame: 6/19/2005 - 6/30/2006 ]
    Average time to success at 0 and 6 months

  • 4. Score (%) on BMV written test at 0 and 6 months [ Time Frame: 6/19/2005 - 6/30/2006 ]
    Score (%) on written test at 0 and 6 months

  • 5. Average likert scale scores on confidence with BMV at 6 months [ Time Frame: 6/19/2005 - 6/30/2006 ]
    Average likert scale scores on confidence with procedures at 6 months

  • IV insertion: 1. Percent successful PIV insertion on simulator at 0 and 6 months [ Time Frame: 6/19/2005 - 6/30/2006 ]
    Percent successful PIV insertion on simulator at 0 and 6 months

  • Score (%) on PIV subcomponent checklist at 0 and 6 months [ Time Frame: 6/19/2005 - 6/30/2006 ]
    Score (%) on subcomponent checklist at 0 and 6 months

  • Score (%) on PIV written test at 0 and 6 months [ Time Frame: 6/19/2005 - 6/30/2006 ]
    Score on written test

  • Average likert scale scores on confidence with PIV at 6 months [ Time Frame: 6/19/2005 - 6/30/2006 ]
    Likert scale score

  • Venipuncture: 1. Percent successful VP insertion on simulator at 0 and 6 months [ Time Frame: 6/19/2005 - 6/30/2006 ]
    % VP successul on simulator

  • 2. Score (%) on VP subcomponent checklist at 0 and 6 months [ Time Frame: 6/19/2005 - 6/30/2006 ]
    Score on checklist

  • 3. Score (%) on VP written test at 0 and 6 months [ Time Frame: 6/19/2005 - 6/30/2006 ]
    Score on written test

  • 4. Average likert scale scores on confidence with VP at 6 months [ Time Frame: 6/19/2005 - 6/30/2006 ]
    Likert score

  • Lumbar puncture: 1. Percentage of atraumatic LP attempts over 6 months [ Time Frame: 6/19/2005 - 6/30/2006 ]
    Successful LPs on patients

  • 2. Score (%) on LP subcomponent checklist on simulator at 6 months [ Time Frame: 6/19/2005 - 6/30/2006 ]
    Score on checklist

  • 3. Score (%) on subcomponent checklist on first live patient LP [ Time Frame: 6/19/2005 - 6/30/2006 ]
    checklist score

  • 4. Number of LP attempts needed to demonstrate competence [ Time Frame: 6/19/2005 - 6/30/2006 ]
    number of LPs

  • 5. Score (%) on LP written test at 0 and 6 months [ Time Frame: 6/19/2005 - 6/30/2006 ]
    Score on written test

  • 6. Average likert scale scores on confidence with LP at 6 months [ Time Frame: 6/19/2005 - 6/30/2006 ]
    Likert score


Enrollment: 38
Study Start Date: June 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Arm

'Formal Curriculum; Low-Fidelity Simulation'

Residents randomized to the intervention arm will receive the study skills training curriculum (the intervention).

Other: Formal Curriculum; Low-Fidelity Simulation
The intervention was a formal procedural skills training curriculum consisting of didactic lectures and simulation training.
No Intervention: Control
Residents randomized to the control arm will receive standard pediatric training.

Detailed 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00115596


Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Association of Pediatric Program Directors
Investigators
Principal Investigator: Michael G Gaies, MD MPH Childrens's Hospital, Boston
  More Information

Responsible Party: Michael Gaies, Instructor in Medicine, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT00115596     History of Changes
Other Study ID Numbers: CH 05-05-040
First Submitted: June 23, 2005
First Posted: June 24, 2005
Last Update Posted: July 21, 2017
Last Verified: July 2017

Keywords provided by Michael Gaies, Boston Children's Hospital:
Procedure
Training
Simulation
Pediatrics
Curriculum
Evaluation


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