NCT00115596

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

1 year

First QC Date

June 23, 2005

Last Update Submit

July 18, 2017

Conditions

Health PersonnelHealthy

Keywords

ProcedureTrainingSimulationPediatricsCurriculumEvaluation

Outcome Measures

Primary Outcomes (4)

  • 1. Percent successful IV placement over 6 months

    % IVs successfully placed

    6/19/2005 - 6/30/2006

  • 2. Percent successful venipunctures over 6 months

    % venipunctures with adequate sample for testing

    6/19/2005 - 6/30/2006

  • 3. Score on lumbar puncture subcomponent checklist on simulator at 6 months

    % steps correct on checklist

    6/19/2005 - 6/30/2006

  • Score on bag mask ventilation 9BMV) subcomponent checklist on simulator at 6 months.

    % steps correct on checklist

    6/19/2005 - 6/30/2006

Secondary Outcomes (19)

  • Bag Mask Ventilation: 1. 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

    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

    6/19/2005 - 6/30/2006

  • 5. Average likert scale scores on confidence with BMV at 6 months

    6/19/2005 - 6/30/2006

  • +14 more secondary outcomes

Study Arms (2)

Intervention Arm

EXPERIMENTAL

'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

Control

NO INTERVENTION

Residents randomized to the control arm will receive standard pediatric training.

Interventions

Formal Curriculum; Low-Fidelity SimulationOTHER

The intervention was a formal procedural skills training curriculum consisting of didactic lectures and simulation training.

Intervention Arm

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Study Officials

  • Michael G Gaies, MD MPH

    Childrens's Hospital, Boston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor in Medicine

Study Record Dates

First Submitted

June 23, 2005

First Posted

June 24, 2005

Study Start

June 1, 2005

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

US(1)