- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00115596
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
Conditions
Intervention / Treatment
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.
Sponsor
Collaborators
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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