Simulation-Based Intrathecal Pump Refill Training (REFILL-IT)
Optimizing Intrathecal Pump Refill Training: A Simulation-Based Study of Learning Curves and Procedural Competence.
Intrathecal drug delivery is an effective treatment option for patients with chronic (non-) cancer pain or spasticity who do not achieve sufficient benefit from conventional therapies. After intrathecal pump implantation, intrathecal pump refilling is an essential postoperative maintenance procedure that requires procedural competence to be performed safely and consistently. Despite the absence of a standardized intrathecal pump refill protocol, the REFFIL-IT study aims to train 40 participants in intrathecal pump refilling. Based on the learning curve during simulation-based training and the number of complete simulated refill procedures required to achieve stable procedural competence, a step-by-step standardized intrathecal pump refill protocol will be developed. The REFILL-IT study aims to contribute to the safe and correct intrathecal pump refilling in patients with chronic (non-) cancer pain and spasticity.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Maarten Moens, MD PhD MBA
- Telefonszám: +3224775514
- E-mail: stimulusresearchgroup@gmail.com
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Lisa Goudman, MSC, PhD, MBA
- E-mail: lisa.goudman@vub.be
Tanulmányi helyek
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Jette, Belgium, 1090
- UZ Brussel/VUB
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Kapcsolatba lépni:
- Maarten Moens
- Telefonszám: +3224775514
- E-mail: stimulusresearchgroup@gmail.com
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Alkutató:
- Ulrike Van Hoey, MSc
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Alkutató:
- Britt Winnepenninckx, MSc
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Kutatásvezető:
- Maarten Moens, MD, PhD, MBA
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Alkutató:
- Lisa Goudman, MSc, PhD, MBA
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- Healthcare professionals
- (Healthcare) students;
- Aged ≥18 years;
- No prior independent performance of intrathecal pump refill procedures;
- Dutch speaking.
Exclusion Criteria:
- Visual impairments preventing participation in stimulated-based intrathecal pump training;
- Conditions such as severe neurological or musculoskeletal disorders affecting hand function that preclude participation in the training.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: Simulation-based intrathecal pump refill training
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The REFILL-IT study consists of two mandatory phases and an optional third clinical phase. During the Knowledge Acquisition Phase, participants will receive theoretical and practical instruction through educational videos and a written step-by-step guide. Progression requires successful completion of a knowledge assessment covering the refill procedure. In the Skill Development Phase, participants will repeatedly perform simulated intrathecal pump refill procedures using explanted SynchroMed II™ (Medtronic) dummy pumps positioned beneath a 15-mm silicone skin pad. Each procedure will be assessed as either successful or unsuccessful to evaluate the development of procedural competence. Participants who achieve stable competence and are physicians legally authorized to perform intrathecal pump refills in Belgium may progress to the Clinical Application Phase, where they will perform refill procedures in patients under the direct supervision of an experienced healthcare professional. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Number of complete simulated intrathecal pump refill procedures required to achieve stable procedural competence
Időkeret: Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
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The number of complete simulated intrathecal pump refill procedures required to achieve stable procedural competence will be determined using Learning Curve Cumulative Sum (LC-CUSUM) analysis. |
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Total Objective Structured Assessment of Technical Skills (OSATS) score per simulated refill procedure
Időkeret: Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
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Each (simulated) refill procedure will be evaluated using an OSATS-based assessment tool, assessing four predefined domains: aseptic technique, correct port access, volume verification, and procedural safety. |
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
|
|
Attempt-level success or failure
Időkeret: Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
|
Each (simulated) refill procedure will be classified as successful or failed based on the OSATS score and the occurrence of critical procedural errors. |
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
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Number and type of critical procedural errors
Időkeret: Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
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The number and type of critical procedural errors occurring during each simulated refill procedure will be recorded. |
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
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|
Number and type of procedural errors
Időkeret: Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
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Non-critical procedural errors, including minor deviations, delays, and technical difficulties, will be recorded during each (simulated) refill procedure. |
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
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|
Proportion of participants achieving stable procedural competence within the predefined training phase
Időkeret: Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
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The number of participants achieving stable procedural competence according to the predefined LC-CUSUM decision rule will be recorded, or until a maximum of 16 complete simulated refill procedures has been reached. |
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
|
|
Number of participants requiring additional supervised practice or remediation after the predefined training phase
Időkeret: Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
|
The number of participants requiring additional supervised practice or remediation will be recorded. |
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
|
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Number of port-access attempts per simulated refill procedure
Időkeret: Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
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The number of port-access attempts per (simulated) refill procedure will be recorded, with a maximum of three attempts per procedure. |
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
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Total procedure time of a complete simulated refill procedure
Időkeret: Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
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The total time required to complete each (simulated) intrathecal pump refill procedure will be recorded. |
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
|
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Time required for individual procedural steps
Időkeret: Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
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The time required for individual procedural steps during a (simulated) intrathecal pump refill procedure will be recorded. |
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
|
Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Egyéb vizsgálati azonosító számok
- 26298_REFILL-IT
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