Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511466
Status:
COMPLETED
Last Update Posted:
None
First Post:
2013-08-09
Brief Title:
Belmont Rapid Infuser Education
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of a Training Model for the Proficient Use of the Belmont Rapid Infuser
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
This study is a randomized non-blinded study Since the investigators are following a quality improvement methodology there is only an intervention group and not a control group All participants will receive the training intervention
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
Participants will be tested with the traditional test method as a first step Based on the outcomes of this test method a decision would be made to conduct the restructured training Traditional method is the current method used which involves oral slide presentation followed by demonstration and written test There will be a video presentation followed by a demonstration by and experienced Anesthesia Tech Restructured training that the investigators are proposing will consist of an oral slide presentation and will follow hands-on assembly and written test The hands-on assembly will be the new training technique that will be different from the original technique
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
Participants will be tested with the traditional test method as a first step Based on the outcomes of this test method a decision would be made to conduct the restructured training Traditional method is the current method used which involves oral slide presentation followed by demonstration and written test There will be a video presentation followed by a demonstration by and experienced Anesthesia Tech Restructured training that the investigators are proposing will consist of an oral slide presentation and will follow hands-on assembly and written test The hands-on assembly will be the new training technique that will be different from the original technique
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None