Knowledge, Attitudes, PracticeIMPROFNCT05952908
Effect of Simulation-based Procedure Training for Novice Cardiac Device Implanters Towards Implant Proficiency
A study testing Proficiency-Based Progression simulation training and Traditional simulation training in people with Knowledge, Attitudes, Practice, run by Jorio Mascheroni at 1 site in Belgium.
Trial summary
This is an educational research study involving novice cardiac device implanters willing to further enhance their device implant skills through optional simulation-based training. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Knowledge, Attitudes, Practice
- What is being tested?
- Proficiency-Based Progression simulation training and Traditional simulation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Mar 2022to 24 Nov 2022
- 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
- Physicians actively practicing cardiac device implantation at time of enrolment
- Minimum 20 pacemaker/defibrillator systems previously implanted as 1st operator
- Minimum 3 cardiac resynchronization therapy (CRT) systems previously implanted at least as 2nd operator
- Familiarity with English language (written and spoken)
Who cannot join
- Having previously implanted ≥ 200 CRT systems as 1st operator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Quality Assured Simulation Training on Cardiac Device Implanter Skills
This is an educational research study involving novice cardiac device implanters willing to further enhance their device implant skills through optional simulation-based training. The goal is to prospectively compare the effect of two different simulation-based training approaches on the quality of operators' implant performance in a simulated environment. The hypothesis is that a novel simulation training curriculum requiring trainees to demonstrate predefined proficiency benchmarks to advance (proficiency-based progression method) would generate superior performances compared to a traditional simulation training curriculum without proficiency requirements but identical content/tools. At the end of the instruction each trainee will perform a final simulated implant procedure which will be (anonymously) video-recorded and consequently scored by independent reviewers using previously validated intraoperative performance metrics. The effect of the two training approaches will be evaluated and performances compared by group for each metric independently.
Read the detailed description
BACKGROUND: In cardiac device implant training, there is no common system to objectively assess trainees' ability to perform tasks at predetermined performance levels prior to in-vivo practice. Patients are potentially exposed to risks related to operators' early learning curve. A novel approach to enhance the learning outcome could be a metric-based, simulation training to proficiency. Such an approach to training is known as proficiency-based progression (PBP) and requires trainees to demonstrate a predefined proficiency benchmark, quantified by validated procedure performance metrics, before proceeding to the next stage of training. Published results in various domains of procedural medicine show that PBP trainees perform ~60% better compared to their non-PBP trained peers. This approach has never been tested for device implant training yet.
INTERVENTION: The training curriculum developed for the study purpose will cover a triple chamber device system implantation (i.e., cardiac resynchronization therapy = CRT) and will comprise two mandatory modules: a self-paced e-learning component and a peer-to-peer simulation-based component at a skill center. The content, the resources and the agenda of the training curriculum will be the same for both study groups; only the criteria for the trainees to proceed through the training stages will differ.
STUDY IMPLICATIONS: Compared to traditional simulation training, metrics-based training to proficiency may ensure a superior, consistent, objectively assessed target-level of operator's performance before they advance to (supervised) in-vivo practice.
- Conditions
- Knowledge, Attitudes, Practice
- Being tested
- Proficiency-Based Progression simulation training, Traditional simulation training
- Keywords
- Proficiency-based progression, Training, Simulation, Metrics
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proficiency-Based Progression simulation trainingOther
The simulation-based training curriculum is delivered - with proficiency requirements - with the aim of further enhancing trainees' implant skills, as an optional supplement to their academic/institutional training.
Traditional simulation trainingOther
The simulation-based training curriculum is delivered - without proficiency requirements - with the aim of further enhancing trainees' implant skills, as an optional supplement to their academic/institutional training.
| Study group | Role | What they receive |
|---|---|---|
| Proficiency-Based Progression training group | Experimental | Trainees in this group will follow the simulation-based implant training curriculum (same content/tools in both study arms) and they will be required to demonstrate a quantitatively defined proficiency benchmark at each training stage to be able to advance to the next stage (proficiency-based progression [PBP] approach). Receives: Other: Proficiency-Based Progression simulation training |
| Traditional training group | Active comparator | Trainees in this group will follow the simulation-based implant training curriculum (same content/tools in both study arms) but they will not be required to demonstrate a quantitatively defined proficiency benchmark at each training stage to be able to advance to the next stage. Receives: Other: Traditional simulation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of procedural Steps Completed in the final skills assessment (median per group)
Procedural Steps Completed is an intraoperative performance metric objectively assessed/scored from each trainee's (anonymous) simulated implant video-recording acquired at the end of the training as a final skills assessment. The analysis will compare the medians of each group.
Measured: 1 hour post-intervention
Number of Errors in the final skills assessment (median per group)
Procedural Errors is an intraoperative performance metric objectively assessed/scored from each trainee's (anonymous) simulated implant video-recording acquired at the end of the training as a final skills assessment. The analysis will compare the medians of each group.
Measured: 1 hour post-intervention
Number of Critical Errors in the final skills assessment (median per group)
Procedural Critical Errors is an intraoperative performance metric objectively assessed/scored from each trainee's (anonymous) simulated implant video-recording acquired at the end of the training as a final skills assessment. The analysis will compare the medians of each group.
Measured: 1 hour post-intervention
Number of Errors All Combined (Errors + Critical Errors) in the final skills assessment (median per group)
Procedural Errors All Combined, represents the total amount of deviations from optimal performance (Errors + Critical Errors) and it's an overall indicator of performance quality. The analysis will compare the medians of each group.
Measured: 1 hour post-intervention
Secondary outcomes (7)
Procedure duration (min) in the final skills assessment (median per group)
Four procedural measures will be derived from video-recordings of the implant performances on the virtual reality simulator: Procedure duration, Fluoroscopy duration, Cineradiography duration, amount of Contrast Media injected. The analysis will compare the medians of each group (each variable is compared independently).
Measured: 1 hour post-intervention
Fluoroscopy duration (min) in the final skills assessment (median per group)
Four procedural measures will be derived from video-recordings of the implant performances on the virtual reality simulator: Procedure duration, Fluoroscopy duration, Cineradiography duration, amount of Contrast Media injected. The analysis will compare the medians of each group (each variable is compared independently).
Measured: 1 hour post-intervention
Cineradiography duration (s) in the final skills assessment (median per group)
Four procedural measures will be derived from video-recordings of the implant performances on the virtual reality simulator: Procedure duration, Fluoroscopy duration, Cineradiography duration, amount of Contrast Media injected. The analysis will compare the medians of each group (each variable is compared independently).
Measured: 1 hour post-intervention
Contrast Media injected (ml) in the final skills assessment (median per group)
Four procedural measures will be derived from video-recordings of the implant performances on the virtual reality simulator: Procedure duration, Fluoroscopy duration, Cineradiography duration, amount of Contrast Media injected. The analysis will compare the medians of each group (each variable is compared independently).
Measured: 1 hour post-intervention
Score obtained in the online knowledge test (percentage of correct answers per group, from 0 [minimum, worst outcome] to 100 [maximum, best outcome])
At the completion of the online component of the training curriculum, trainees are required to take a summative knowledge test online. The scale title will be "Percentage of correct answers in the online assessment". The outcome will span from 0 [minimum, worst outcome] to 100 [maximum, best outcome].
Measured: 1 hour post-intervention
Number of trainees per study group demonstrating the proficiency benchmark in the final assessment
The number of trainees per study group demonstrating the proficiency benchmark in the video-recorded performance at the end of the training curriculum.
Measured: 1 hour post-intervention
Participants' satisfaction level at the end of the training curriculum (mean score per group on a Likert scale, from 0 [minimum, worst outcome] to 10 [maximum, best outcome])
Participants' satisfaction level regarding the training received expressed on a Likert scale; feedback will be provided anonymously through the training evaluation forms filled at the end of the program. The scale title will be "Probability of recommending the curriculum to a peer". The outcome will span from 0 [minimum, worst outcome] to 10 [maximum, best outcome].
Measured: 3 hours post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start8 Mar 2022
- Primary completion24 Nov 2022
- Study completion24 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jorio Mascheroni
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jorio Mascheroni, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Jorio Mascheroni, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952908
- Sponsor's protocol ID
- KUL0912559-001
- Acronym
- IMPROF
- Status last verified
- Jul 2023
- First submitted
- 30 Jun 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data that underlie results in publications, as well as data dictionaries, will be made available when access criteria are met.
Publications
Mascheroni J, Stockburger M, Patwala A, Mont L, Rao A, Retzlaff H, Garweg C, Verbelen T, Gallagher AG. Effect of Metrics-Based Simulation Training to Proficiency on Procedure Quality and Errors Among Novice Cardiac Device Implanters: The IMPROF Randomized Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2322750. doi: 10.1001/jamanetworkopen.2023.22750.
PubMed 37651144
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Quality Assured Simulation Training on Cardiac Device Implanter Skills
- ClinicalTrials.gov ID
- NCT05952908
- Acronym / sponsor ID
- IMPROF / KUL0912559-001
- Conditions
- Knowledge, Attitudes, Practice
- Keywords
- Proficiency-based progression, Training, Simulation, Metrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Jorio MascheroniUniversity, hospital or other
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 24 Nov 2022 (actual)
- Study completion
- 24 Nov 2022 (actual)
- First posted
- 19 Jul 2023 (actual)
- 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 is an educational research study involving novice cardiac device implanters willing to further enhance their device implant skills through optional simulation-based training. The goal is to prospectively compare the effect of two different simulation-based training approaches on the quality of operators' implant performance in a simulated environment. The hypothesis is that a novel simulation training curriculum requiring trainees to demonstrate predefined proficiency benchmarks to advance (proficiency-based progression method) would generate superior performances compared to a traditional simulation training curriculum without proficiency requirements but identical content/tools. At the end of the instruction each trainee will perform a final simulated implant procedure which will be (anonymously) video-recorded and consequently scored by independent reviewers using previously validated intraoperative performance metrics. The effect of the two training approaches will be evaluated and performances compared by group for each metric independently.
Detailed description
BACKGROUND: In cardiac device implant training, there is no common system to objectively assess trainees' ability to perform tasks at predetermined performance levels prior to in-vivo practice. Patients are potentially exposed to risks related to operators' early learning curve. A novel approach to enhance the learning outcome could be a metric-based, simulation training to proficiency. Such an approach to training is known as proficiency-based progression (PBP) and requires trainees to demonstrate a predefined proficiency benchmark, quantified by validated procedure performance metrics, before proceeding to the next stage of training. Published results in various domains of procedural medicine show that PBP trainees perform ~60% better compared to their non-PBP trained peers. This approach has never been tested for device implant training yet.
INTERVENTION: The training curriculum developed for the study purpose will cover a triple chamber device system implantation (i.e., cardiac resynchronization therapy = CRT) and will comprise two mandatory modules: a self-paced e-learning component and a peer-to-peer simulation-based component at a skill center. The content, the resources and the agenda of the training curriculum will be the same for both study groups; only the criteria for the trainees to proceed through the training stages will differ.
STUDY IMPLICATIONS: Compared to traditional simulation training, metrics-based training to proficiency may ensure a superior, consistent, objectively assessed target-level of operator's performance before they advance to (supervised) in-vivo practice.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proficiency-Based Progression training group | Experimental | Other: Proficiency-Based Progression simulation trainingTrainees in this group will follow the simulation-based implant training curriculum (same content/tools in both study arms) and they will be required to demonstrate a quantitatively defined proficiency benchmark at each training stage to be able to advance to the next stage (proficiency-based progression [PBP] approach). |
| Traditional training group | Active comparator | Other: Traditional simulation trainingTrainees in this group will follow the simulation-based implant training curriculum (same content/tools in both study arms) but they will not be required to demonstrate a quantitatively defined proficiency benchmark at each training stage to be able to advance to the next stage. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Physicians actively practicing cardiac device implantation at time of enrolment
- Minimum 20 pacemaker/defibrillator systems previously implanted as 1st operator
- Minimum 3 cardiac resynchronization therapy (CRT) systems previously implanted at least as 2nd operator
- Familiarity with English language (written and spoken)
Key exclusion criteria (1 listed)
- Having previously implanted ≥ 200 CRT systems as 1st operator
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 |
|---|---|---|
| Proficiency-Based Progression simulation trainingThe simulation-based training curriculum is delivered - with proficiency requirements - with the aim of further enhancing trainees' implant skills, as an optional supplement to their academic/institutional training. | Other | Proficiency-Based Progression training group |
| Traditional simulation trainingThe simulation-based training curriculum is delivered - without proficiency requirements - with the aim of further enhancing trainees' implant skills, as an optional supplement to their academic/institutional training. | Other | Traditional training group |
Primary outcome
Number of procedural Steps Completed in the final skills assessment (median per group)
Time frame: 1 hour post-intervention
Procedural Steps Completed is an intraoperative performance metric objectively assessed/scored from each trainee's (anonymous) simulated implant video-recording acquired at the end of the training as a final skills assessment. The analysis will compare the medians of each group.
Number of Errors in the final skills assessment (median per group)
Time frame: 1 hour post-intervention
Procedural Errors is an intraoperative performance metric objectively assessed/scored from each trainee's (anonymous) simulated implant video-recording acquired at the end of the training as a final skills assessment. The analysis will compare the medians of each group.
Number of Critical Errors in the final skills assessment (median per group)
Time frame: 1 hour post-intervention
Procedural Critical Errors is an intraoperative performance metric objectively assessed/scored from each trainee's (anonymous) simulated implant video-recording acquired at the end of the training as a final skills assessment. The analysis will compare the medians of each group.
Number of Errors All Combined (Errors + Critical Errors) in the final skills assessment (median per group)
Time frame: 1 hour post-intervention
Procedural Errors All Combined, represents the total amount of deviations from optimal performance (Errors + Critical Errors) and it's an overall indicator of performance quality. The analysis will compare the medians of each group.
7 secondary outcomes
Procedure duration (min) in the final skills assessment (median per group)
Time frame: 1 hour post-intervention
Fluoroscopy duration (min) in the final skills assessment (median per group)
Time frame: 1 hour post-intervention
Cineradiography duration (s) in the final skills assessment (median per group)
Time frame: 1 hour post-intervention
Contrast Media injected (ml) in the final skills assessment (median per group)
Time frame: 1 hour post-intervention
Score obtained in the online knowledge test (percentage of correct answers per group, from 0 [minimum, worst outcome] to 100 [maximum, best outcome])
Time frame: 1 hour post-intervention
Number of trainees per study group demonstrating the proficiency benchmark in the final assessment
Time frame: 1 hour post-intervention
Participants' satisfaction level at the end of the training curriculum (mean score per group on a Likert scale, from 0 [minimum, worst outcome] to 10 [maximum, best outcome])
Time frame: 3 hours post-intervention
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 19 Jul 2023.
- Derived from this study: PubMed 37651144Mascheroni J, Stockburger M, Patwala A, Mont L, Rao A, Retzlaff H, Garweg C, Verbelen T, Gallagher AG. Effect of Metrics-Based Simulation Training to Proficiency on Procedure Quality and Errors Among Novice Cardiac Device Implanters: The IMPROF Randomized Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2322750. doi: 10.1001/jamanetworkopen.2023.22750.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data that underlie results in publications, as well as data dictionaries, will be made available when access criteria are met.
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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.
Jorio Mascheroni principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proficiency-Based Progression simulation training and Traditional simulation training in people with Knowledge, Attitudes, Practice, run by Jorio Mascheroni at 1 site in Belgium.
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 4 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 19 Jul 2023. 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 Belgium. 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?
Number of procedural Steps Completed in the final skills assessment (median per group) (time frame: 1 hour post-intervention). 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?
On the ClinicalTrials.gov record for NCT05952908, which also lists 1 linked publication.
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 19 Jul 2023.