Reforming Pediatric Procedural Training

July 18, 2017 updated by: Michael Gaies, Boston Children's Hospital

Reforming Pediatric Procedural Training: Developing an Evidence-Based Curriculum

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

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

38

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

    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm

'Formal Curriculum; Low-Fidelity Simulation'

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Percent successful IV placement over 6 months
Time Frame: 6/19/2005 - 6/30/2006
% IVs successfully placed
6/19/2005 - 6/30/2006
2. Percent successful venipunctures over 6 months
Time Frame: 6/19/2005 - 6/30/2006
% venipunctures with adequate sample for testing
6/19/2005 - 6/30/2006
3. Score on lumbar puncture subcomponent checklist on simulator at 6 months
Time Frame: 6/19/2005 - 6/30/2006
% steps correct on checklist
6/19/2005 - 6/30/2006
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
6/19/2005 - 6/30/2006

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6/19/2005 - 6/30/2006
Average score on BMV checklist at 6 months
Time Frame: 6/19/2005 - 6/30/2006
Average score on subcomponent checklist at 6 months
6/19/2005 - 6/30/2006
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
6/19/2005 - 6/30/2006
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
6/19/2005 - 6/30/2006
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
6/19/2005 - 6/30/2006
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
6/19/2005 - 6/30/2006
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
6/19/2005 - 6/30/2006
Score (%) on PIV written test at 0 and 6 months
Time Frame: 6/19/2005 - 6/30/2006
Score on written test
6/19/2005 - 6/30/2006
Average likert scale scores on confidence with PIV at 6 months
Time Frame: 6/19/2005 - 6/30/2006
Likert scale score
6/19/2005 - 6/30/2006
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
6/19/2005 - 6/30/2006
2. Score (%) on VP subcomponent checklist at 0 and 6 months
Time Frame: 6/19/2005 - 6/30/2006
Score on checklist
6/19/2005 - 6/30/2006
3. Score (%) on VP written test at 0 and 6 months
Time Frame: 6/19/2005 - 6/30/2006
Score on written test
6/19/2005 - 6/30/2006
4. Average likert scale scores on confidence with VP at 6 months
Time Frame: 6/19/2005 - 6/30/2006
Likert score
6/19/2005 - 6/30/2006
Lumbar puncture: 1. Percentage of atraumatic LP attempts over 6 months
Time Frame: 6/19/2005 - 6/30/2006
Successful LPs on patients
6/19/2005 - 6/30/2006
2. Score (%) on LP subcomponent checklist on simulator at 6 months
Time Frame: 6/19/2005 - 6/30/2006
Score on checklist
6/19/2005 - 6/30/2006
3. Score (%) on subcomponent checklist on first live patient LP
Time Frame: 6/19/2005 - 6/30/2006
checklist score
6/19/2005 - 6/30/2006
4. Number of LP attempts needed to demonstrate competence
Time Frame: 6/19/2005 - 6/30/2006
number of LPs
6/19/2005 - 6/30/2006
5. Score (%) on LP written test at 0 and 6 months
Time Frame: 6/19/2005 - 6/30/2006
Score on written test
6/19/2005 - 6/30/2006
6. Average likert scale scores on confidence with LP at 6 months
Time Frame: 6/19/2005 - 6/30/2006
Likert score
6/19/2005 - 6/30/2006

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael G Gaies, MD MPH, Childrens's Hospital, Boston

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, 2005

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

June 23, 2005

First Submitted That Met QC Criteria

June 26, 2005

First Posted (Estimate)

June 24, 2005

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • CH 05-05-040

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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