Health PersonnelNCT00115596
Reforming Pediatric Procedural Training
A study testing Formal Curriculum; Low-Fidelity Simulation in people with Health Personnel and Healthy, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This study is randomized trial of a procedural skills training curriculum utilizing simulation to teach basic procedural skills to pediatric residents. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Personnel, Healthy
- What is being tested?
- Formal Curriculum; Low-Fidelity Simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jun 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pediatric Intern in the Boston Combined Residency Program for AY '05-'06
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: 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.
Read the 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.
- Conditions
- Health Personnel, Healthy
- Being tested
- Formal Curriculum; Low-Fidelity Simulation
- Keywords
- Procedure, Training, Simulation, Pediatrics, Curriculum, Evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formal Curriculum; Low-Fidelity SimulationOther
The intervention was a formal procedural skills training curriculum consisting of didactic lectures and simulation training.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 'Formal Curriculum; Low-Fidelity Simulation'
Residents randomized to the intervention arm will receive the study skills training curriculum (the intervention). Receives: Other: Formal Curriculum; Low-Fidelity Simulation |
| Control | No intervention | Residents randomized to the control arm will receive standard pediatric training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Percent successful IV placement over 6 months
% IVs successfully placed
Measured: 6/19/2005 - 6/30/2006
2. Percent successful venipunctures over 6 months
% venipunctures with adequate sample for testing
Measured: 6/19/2005 - 6/30/2006
3. Score on lumbar puncture subcomponent checklist on simulator at 6 months
% steps correct on checklist
Measured: 6/19/2005 - 6/30/2006
Score on bag mask ventilation 9BMV) subcomponent checklist on simulator at 6 months.
% steps correct on checklist
Measured: 6/19/2005 - 6/30/2006
Secondary outcomes (19)
Bag Mask Ventilation: 1. Percentage able to successfully ventilate simulator at 0 and 6 months
Percentage able to successfully ventilate simulator at 0 and 6 months
Measured: 6/19/2005 - 6/30/2006
Average score on BMV checklist at 6 months
Average score on subcomponent checklist at 6 months
Measured: 6/19/2005 - 6/30/2006
Average time to success at 0 and 6 months
Average time to success at 0 and 6 months
Measured: 6/19/2005 - 6/30/2006
4. Score (%) on BMV written test at 0 and 6 months
Score (%) on written test at 0 and 6 months
Measured: 6/19/2005 - 6/30/2006
5. Average likert scale scores on confidence with BMV at 6 months
Average likert scale scores on confidence with procedures at 6 months
Measured: 6/19/2005 - 6/30/2006
IV insertion: 1. Percent successful PIV insertion on simulator at 0 and 6 months
Percent successful PIV insertion on simulator at 0 and 6 months
Measured: 6/19/2005 - 6/30/2006
Score (%) on PIV subcomponent checklist at 0 and 6 months
Score (%) on subcomponent checklist at 0 and 6 months
Measured: 6/19/2005 - 6/30/2006
Score (%) on PIV written test at 0 and 6 months
Score on written test
Measured: 6/19/2005 - 6/30/2006
Average likert scale scores on confidence with PIV at 6 months
Likert scale score
Measured: 6/19/2005 - 6/30/2006
Venipuncture: 1. Percent successful VP insertion on simulator at 0 and 6 months
% VP successul on simulator
Measured: 6/19/2005 - 6/30/2006
2. Score (%) on VP subcomponent checklist at 0 and 6 months
Score on checklist
Measured: 6/19/2005 - 6/30/2006
3. Score (%) on VP written test at 0 and 6 months
Score on written test
Measured: 6/19/2005 - 6/30/2006
4. Average likert scale scores on confidence with VP at 6 months
Likert score
Measured: 6/19/2005 - 6/30/2006
Lumbar puncture: 1. Percentage of atraumatic LP attempts over 6 months
Successful LPs on patients
Measured: 6/19/2005 - 6/30/2006
2. Score (%) on LP subcomponent checklist on simulator at 6 months
Score on checklist
Measured: 6/19/2005 - 6/30/2006
3. Score (%) on subcomponent checklist on first live patient LP
checklist score
Measured: 6/19/2005 - 6/30/2006
4. Number of LP attempts needed to demonstrate competence
number of LPs
Measured: 6/19/2005 - 6/30/2006
5. Score (%) on LP written test at 0 and 6 months
Score on written test
Measured: 6/19/2005 - 6/30/2006
6. Average likert scale scores on confidence with LP at 6 months
Likert score
Measured: 6/19/2005 - 6/30/2006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2005 (estimated)
- Study startJun 2005
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health PersonnelStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Association of Pediatric Program Directors
- Responsible party
- Principal investigator, Michael Gaies, Boston Children's Hospital
- Investigators
- Michael G Gaies, MD MPH, Principal investigator, Childrens's Hospital, Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115596
- Sponsor's protocol ID
- CH 05-05-040
- Status last verified
- Jul 2017
- First submitted
- 23 Jun 2005
- Last updated
- 21 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reforming Pediatric Procedural Training: Developing an Evidence-Based Curriculum
- ClinicalTrials.gov ID
- NCT00115596
- Acronym / sponsor ID
- CH 05-05-040
- Conditions
- Health Personnel, Healthy
- Keywords
- Procedure, Training, Simulation, Pediatrics, Curriculum, Evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Association of Pediatric Program Directors
- Study start
- Jun 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 24 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is randomized trial of a procedural skills training curriculum utilizing simulation to teach basic procedural skills to pediatric residents.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Formal Curriculum; Low-Fidelity Simulation'Formal Curriculum; Low-Fidelity Simulation' Residents randomized to the intervention arm will receive the study skills training curriculum (the intervention). |
| Control | No intervention | –Residents randomized to the control arm will receive standard pediatric training. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pediatric Intern in the Boston Combined Residency Program for AY '05-'06
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formal Curriculum; Low-Fidelity SimulationThe intervention was a formal procedural skills training curriculum consisting of didactic lectures and simulation training. | Other | Intervention Arm |
Primary outcome
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
19 secondary outcomes
Bag Mask Ventilation: 1. Percentage able to successfully ventilate simulator at 0 and 6 months
Time frame: 6/19/2005 - 6/30/2006
Average score on BMV checklist at 6 months
Time frame: 6/19/2005 - 6/30/2006
Average time to success at 0 and 6 months
Time frame: 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
5. Average likert scale scores on confidence with BMV at 6 months
Time frame: 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
Score (%) on PIV subcomponent checklist at 0 and 6 months
Time frame: 6/19/2005 - 6/30/2006
Score (%) on PIV written test at 0 and 6 months
Time frame: 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
Venipuncture: 1. Percent successful VP insertion on simulator at 0 and 6 months
Time frame: 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
3. Score (%) on VP written test at 0 and 6 months
Time frame: 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
Lumbar puncture: 1. Percentage of atraumatic LP attempts over 6 months
Time frame: 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
3. Score (%) on subcomponent checklist on first live patient LP
Time frame: 6/19/2005 - 6/30/2006
4. Number of LP attempts needed to demonstrate competence
Time frame: 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
6. Average likert scale scores on confidence with LP at 6 months
Time frame: 6/19/2005 - 6/30/2006
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael G Gaies, MD MPH principal investigator
Childrens's Hospital, Boston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formal Curriculum; Low-Fidelity Simulation in people with Health Personnel and Healthy, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Percent successful IV placement over 6 months (time frame: 6/19/2005 - 6/30/2006). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017; AzTrials last refreshed its copy on 28 Oct 2026.