Reforming Pediatric Procedural Training

• Sponsor: Boston Children's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00115596
• Collaborator: Association of Pediatric Program Directors (Other)
• Enrollment: 38
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Health Personnel; Healthy	Other: Formal Curriculum; Low-Fidelity Simulation	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Reforming Pediatric Procedural Training: Developing an Evidence-Based Curriculum
• Study Start Date: Jun 1, 2005
• Actual Primary Completion Date: Jun 1, 2006
• Actual Study Completion Date: Jun 1, 2006

Arms and Interventions

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).	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.

Outcome Measures

Primary Outcome Measures

1. 1. Percent successful IV placement over 6 months [6/19/2005 - 6/30/2006]

   % IVs successfully placed

2. 2. Percent successful venipunctures over 6 months [6/19/2005 - 6/30/2006]

   % venipunctures with adequate sample for testing

3. 3. Score on lumbar puncture subcomponent checklist on simulator at 6 months [6/19/2005 - 6/30/2006]

   % steps correct on checklist

4. Score on bag mask ventilation 9BMV) subcomponent checklist on simulator at 6 months. [6/19/2005 - 6/30/2006]

   % steps correct on checklist

Secondary Outcome Measures

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

   Percentage able to successfully ventilate simulator at 0 and 6 months

2. Average score on BMV checklist at 6 months [6/19/2005 - 6/30/2006]

   Average score on subcomponent checklist at 6 months

3. Average time to success at 0 and 6 months [6/19/2005 - 6/30/2006]

   Average time to success at 0 and 6 months

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

   Score (%) on written test at 0 and 6 months

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

   Average likert scale scores on confidence with procedures at 6 months

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

   Percent successful PIV insertion on simulator at 0 and 6 months

7. Score (%) on PIV subcomponent checklist at 0 and 6 months [6/19/2005 - 6/30/2006]

   Score (%) on subcomponent checklist at 0 and 6 months

8. Score (%) on PIV written test at 0 and 6 months [6/19/2005 - 6/30/2006]

   Score on written test

9. Average likert scale scores on confidence with PIV at 6 months [6/19/2005 - 6/30/2006]

   Likert scale score

10. Venipuncture: 1. Percent successful VP insertion on simulator at 0 and 6 months [6/19/2005 - 6/30/2006]

    % VP successul on simulator

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

    Score on checklist

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

    Score on written test

13. 4. Average likert scale scores on confidence with VP at 6 months [6/19/2005 - 6/30/2006]

    Likert score

14. Lumbar puncture: 1. Percentage of atraumatic LP attempts over 6 months [6/19/2005 - 6/30/2006]

    Successful LPs on patients

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

    Score on checklist

16. 3. Score (%) on subcomponent checklist on first live patient LP [6/19/2005 - 6/30/2006]

    checklist score

17. 4. Number of LP attempts needed to demonstrate competence [6/19/2005 - 6/30/2006]

    number of LPs

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

    Score on written test

19. 6. Average likert scale scores on confidence with LP at 6 months [6/19/2005 - 6/30/2006]

    Likert score

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Gaies, Instructor in Medicine, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT00115596
• Other Study ID Numbers: CH 05-05-040
• First Posted: Jun 24, 2005
• Last Update Posted: Jul 21, 2017
• Last Verified: Jul 1, 2017

• Keywords provided by Michael Gaies, Instructor in Medicine, Boston Children's Hospital: Procedure; Training; Simulation; Pediatrics; Curriculum; Evaluation

Study Results

No Results Posted as of Jul 21, 2017