NCT06511466

Brief Summary

The Belmont Rapid Infuser (BRI) represents medical equipment with potential to elicit serious injury. The device is used infrequently and at irregular time of day which makes training and competency of operation difficult to ensure. In the investigators institution BRI is used infrequently, usually for pediatric trauma cases and liver transplant cases. The current teaching module for BRI includes oral slide presentation and live demonstration of BRI assembly and a written test. The effectiveness of this module has never been tested. The investigators central hypothesis is that modified training will significantly increase proficiency rate. The current traditional teaching module is insufficient to retain knowledge and be proficient. The investigators plan to study the current teaching module (traditional test method) to evaluate its effectiveness in acquisition of proficiency and retention of knowledge and skills. The aims of this study are: Aim 1. To evaluate the current method of teaching on proficient use of the BRI, Hypothesis: The use of traditional test method is not effective as less than 50% will pass in the first attempt. Aim 2. Re-design the teaching module if necessary to optimize the method if the current method is found to be inadequate Hypothesis: Restructured test that provides a hand-on training as opposed to only an oral presentation with the traditional test will be associated with a higher pass rate (\>80%). Aim 3. To perform the success with BRI assembly in clinician pairs versus a single clinician. Hypothesis: Working in pairs is better than working as a single person in setting up the BRI within the recommended time limit. Aim 4: To better define proficiency with the use of the BRI with respect to retention of knowledge and skills after initial teaching and successful tests. Hypothesis: Retention at 3 months is required irrespective of the initial training method in order to retain competency. Retention at 3 months will be higher with the restructured training than with the traditional training method. The investigators will employ a quality improvement methodology invoking a PDSA (Plan-Do-Study Act) ramp to evaluate and improve the training model as necessary. JHACO requires that all equipment users be trained annually in proper operating procedures for the equipment they use and that the training is documented. The investigators propose that retraining may have to be done more frequently in order to retain knowledge especially when this knowledge is to be used during emergency care of children. Medical equipment in the OR may be divided into 4 categories based on the frequency of use and risk of injury. BRI belongs to the category of low frequency of use, but high risk of injury. These categories of medical equipment will require different strategies for teaching and training that need to be explored. If the investigators current teaching module is found to be an effective one, it could be replicated for other types of medical equipment as well as spread to other institutions that use similar equipment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2013

Longer than P75 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2013

Completed
9.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
Last Updated

July 22, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

August 9, 2013

Last Update Submit

July 16, 2024

Conditions

Keywords

Education

Outcome Measures

Primary Outcomes (1)

  • Proficiency

    Primary outcome: proficiency: composite score of pass - pass on BRI assembly and pass on knowledge test.

    July 2013

Secondary Outcomes (1)

  • Retention

    June 2014

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Anesthesia Faculty, Fellows and CRNA's

Study participants for phase 1 will include subjects in each of following categories: faculty, certified registered nurse anesthetists (CRNA), Registered Nurses and pediatric anesthesia fellows. Participants will be recruited from the Department of Anesthesia with no attention to gender, race, age, or socioeconomic status. -

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Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2013

First Posted

July 22, 2024

Study Start

February 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2023

Last Updated

July 22, 2024

Record last verified: 2024-07