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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Maarten Moens, MD PhD MBA
- 電話番号：+3224775514
- メール：stimulusresearchgroup@gmail.com
研究連絡先のバックアップ
- 名前：Lisa Goudman, MSC, PhD, MBA
- メール：lisa.goudman@vub.be
研究場所
-
-
-
Jette、ベルギー、1090
- UZ Brussel/VUB
-
コンタクト：
- Maarten Moens
- 電話番号：+3224775514
- メール：stimulusresearchgroup@gmail.com
-
副調査官：
- Ulrike Van Hoey, MSc
-
副調査官：
- Britt Winnepenninckx, MSc
-
主任研究者：
- Maarten Moens, MD, PhD, MBA
-
副調査官：
- Lisa Goudman, MSc, PhD, MBA
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Simulation-based intrathecal pump refill training
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of complete simulated intrathecal pump refill procedures required to achieve stable procedural competence
時間枠：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 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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total Objective Structured Assessment of Technical Skills (OSATS) score per simulated refill procedure
時間枠：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 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
時間枠：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
|
|
Number and type of critical procedural errors
時間枠：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 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
|
|
Number and type of procedural errors
時間枠：Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
|
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
|
|
Proportion of participants achieving stable procedural competence within the predefined training phase
時間枠：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 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
時間枠：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
|
|
Number of port-access attempts per simulated refill procedure
時間枠：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 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
|
|
Total procedure time of a complete simulated refill procedure
時間枠：Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
|
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
|
|
Time required for individual procedural steps
時間枠：Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
|
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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 26298_REFILL-IT
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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