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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Maarten Moens, MD PhD MBA
- 전화번호: +3224775514
- 이메일: stimulusresearchgroup@gmail.com
연구 연락처 백업
- 이름: Lisa Goudman, MSC, PhD, MBA
- 이메일: lisa.goudman@vub.be
연구 장소
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Jette, 벨기에, 1090
- UZ Brussel/VUB
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연락하다:
- Maarten Moens
- 전화번호: +3224775514
- 이메일: stimulusresearchgroup@gmail.com
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부수사관:
- Ulrike Van Hoey, MSc
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부수사관:
- Britt Winnepenninckx, MSc
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수석 연구원:
- Maarten Moens, MD, PhD, MBA
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부수사관:
- Lisa Goudman, MSc, PhD, MBA
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of complete simulated intrathecal pump refill procedures required to achieve stable procedural competence
기간: 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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total Objective Structured Assessment of Technical Skills (OSATS) score per simulated refill procedure
기간: 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
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Attempt-level success or failure
기간: 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 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
기간: 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
기간: 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
기간: 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
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Number of participants requiring additional supervised practice or remediation after the predefined training phase
기간: 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 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 26298_REFILL-IT
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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