- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07367906
디지털 마이크로러닝과 간호대학생의 환자 안전 (DigiM-2026)
외과 임상 실습 전 간호대학생의 환자 안전 인식과 임상 의사 결정에 대한 디지털 마이크로러닝의 효과: 무작위 대조 시험
이 무작위 대조군 연구는 외과 임상 실습을 시작하기 전 간호학생들을 대상으로 환자 안전 중심 디지털 마이크로러닝 프로그램의 효과를 평가하는 것을 목표로 합니다.
간호학생들은 교실 학습에서 임상 환경으로의 전환 과정에서 환자 안전 및 임상 의사 결정과 관련된 어려움을 종종 직면합니다. 본 연구는 짧고 체계적인 디지털 학습 모듈이 환자 안전 인식, 임상 오류 인식 및 의사 결정 능력을 향상시킬 수 있는지 여부를 검토할 것입니다.
2학년 간호학 학부생들은 디지털 마이크로러닝 중재군과 표준 교육을 받는 대조군 중 하나에 무작위로 배정될 것입니다. 결과는 중재 전, 중재 직후 및 임상 실습 첫 주 동안 측정될 것입니다.
연구 개요
상세 설명
간호대학 학생들에게 있어 임상실습 전 교육에서 임상실습으로의 전환은 환자 안전에 있어 중요한 시기입니다. 이 단계에서는 제한된 임상 경험과 함께 증가한 책임이 환자 안전 및 임상 의사결정과 관련된 오류 위험을 증가시킬 수 있습니다. 따라서 임상실습 전에 환자 안전 인식과 인지적 준비도를 강화하는 교육 전략이 필수적입니다.
본 연구는 단일 기관, 평행 그룹, 무작위 대조 시험으로 설계되었습니다. 아그리 이브라힘 체첸 대학교 건강과학대학 간호학과에서 진행될 예정입니다. 참가자는 수술 임상실습을 처음 시작할 준비를 하고 있는 간호학과 2학년 학부생으로 구성됩니다.
기초 평가 후, 적격 참가자는 성별과 학점 평균을 기준으로 한 층화 무작위 배정을 통해 중재 그룹 또는 대조 그룹에 무작위로 배정됩니다. 중재 그룹은 연속 7일 동안 온라인으로 제공되는 환자 안전 중심 디지털 마이크로러닝 프로그램을 받게 됩니다. 이 프로그램은 각각 약 3~5분 동안 지속되는 짧은 시나리오 기반 모듈로 구성되며, 환자 안전 위험, 임상 오류 인식, 우선순위 설정, 스트레스 상황에서의 의사결정과 같은 주제를 다룹니다. 참가자는 일일 시간 제한 내에서 모듈에 유연하게 접근할 수 있습니다.
대조 그룹은 추가 중재 없이 간호학 학부 교육과정의 일환으로 표준 환자 안전 교육을 받게 됩니다.
결과 측정은 세 시점에서 수집됩니다: 중재 전 기초 시점(T0), 중재 완료 직후(T1), 수술 임상실습 첫 주 동안(T2). 주요 결과에는 환자 안전 인식과 임상 오류 인식 수행도의 변화가 포함됩니다. 부차적 결과에는 스트레스 상황에서의 임상 의사결정, 임상실습에 대한 인지된 준비도, 자신감, 디지털 마이크로러닝 프로그램의 수용도가 포함됩니다.
본 연구는 교육적 중재만 포함하며, 침습적 시술, 약물 또는 의료기기를 포함하지 않습니다. 참여는 자발적이며, 모든 참가자로부터 서면 동의서를 받을 예정입니다. 이 연구는 윤리 심의를 제출하였으며, 인간 참가자를 포함하는 연구에 관한 윤리 원칙에 따라 진행될 것입니다.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Merkez
-
AĞRI, Merkez, 터키 (Türkiye), 04100
- Agri Ibrahim Cecen University Faculty of Health Sciences
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- 간호학 2학년 학부생
- 보건과학대학 간호학과에 재학 중
- 처음으로 수술 임상 실습을 시작할 준비 중
- 만 18세 이상
- 참여 의사가 있고 서면 동의서를 작성할 수 있음
제외 기준:
- 이전 수술 임상 실습 경험
- 이전 전문 간호 또는 의료 업무 경험
- 기초 평가 미완료
- 참여 거부 또는 동의 철회
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Digital Microlearning Intervention Group
Participants received a seven-day patient-safety-focused digital microlearning program in addition to standard education before surgical clinical practice.
|
A structured, mobile-optimized digital microlearning program delivered asynchronously over seven consecutive days.
Participants completed one scenario-based module per day, lasting approximately 3-5 minutes.
Each module included a surgical patient-safety scenario, a pause to identify the risk, a forced-choice retrieval question, corrective feedback, and a cue-action takeaway.
Content covered patient identification, medication safety, documentation omissions, deterioration cues, falls and other safety risks, prioritization, escalation, and clinical decision-making under stress.
|
|
간섭 없음: Control Group Standard Education
Participants received the existing undergraduate curriculum without additional digital microlearning.
Standard education consisted of two two-hour surgical patient-safety lectures and a written guideline.
Participants then completed seven weeks of routine surgical clinical practice, one day per week, with the same usual supervision as the intervention group.
The control condition was not attention matched.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Clinical Error Recognition Performance at Clinical Week 7 (T3)
기간: Baseline before the program (T0), immediately after completion of the seven-day intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3; principal endpoint).
|
Clinical error recognition was assessed using alternate scenario-based forms drawn from an expert-reviewed bank of 15 retained surgical patient-safety scenarios.
Each assessment form contained 10 scored scenarios covering patient identification, medication safety, documentation, deterioration, falls, and escalation.
Each response was scored 1 for correct identification of the safety error and 0 for an incorrect or absent identification.
The form score was converted to a 0-100 scale as (number correct/10) × 100, yielding scores in 10-point units; higher scores indicate better clinical error recognition.
Alternate forms used patients, clinical cues, and action sequences distinct from the intervention scenarios.
T3 was the principal endpoint; T0, T1, and T2 measurements described the outcome trajectory.
|
Baseline before the program (T0), immediately after completion of the seven-day intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3; principal endpoint).
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Clinical Decision-Making Under Stress
기간: Baseline before the program (T0), immediately after completion of the seven-day intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3).
|
Clinical decision-making under stress was assessed using scenario-based evaluations that required participants to recognize, prioritize, and respond to patient-safety problems in stressful surgical clinical situations.
Scores were converted to a 0-100 scale, with higher scores indicating better decision-making performance under stress.
|
Baseline before the program (T0), immediately after completion of the seven-day intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3).
|
|
Patient Safety Awareness
기간: Baseline before the program (T0), immediately after completion of the seven-day intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3).
|
Patient-safety awareness was assessed using the Patient Safety Awareness Questionnaire, which evaluates understanding of patient-safety principles, recognition of safety risks, and safe practices relevant to surgical care.
Scores were converted to a 0-100 scale, with higher scores indicating greater patient-safety awareness.
|
Baseline before the program (T0), immediately after completion of the seven-day intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3).
|
|
Clinical Practice Readiness
기간: Baseline before the program (T0), immediately after completion of the seven-day intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3).
|
Perceived readiness for surgical clinical practice was assessed using the 12-item Clinical Placement Readiness Scale.
Item responses were transformed to a 0-100 score for analysis, with higher scores indicating greater perceived readiness for clinical practice.
|
Baseline before the program (T0), immediately after completion of the seven-day intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3).
|
|
Clinical Self-Confidence
기간: Baseline before the program (T0), immediately after completion of the seven-day intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3).
|
Clinical self-confidence was assessed using a structured self-confidence measure addressing preparedness and the performance of patient-safety actions within supervised surgical clinical practice.
Scores were converted to a 0-100 scale, with higher scores indicating greater clinical self-confidence.
|
Baseline before the program (T0), immediately after completion of the seven-day intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3).
|
|
Acceptability of the Digital Microlearning Program
기간: Immediately after completion of the seven-day intervention (T1).
|
Acceptability was assessed in the intervention group using a post-intervention questionnaire covering satisfaction, perceived usefulness, usability, and relevance to surgical clinical practice.
The total score ranged from 1 to 5, with higher scores indicating greater acceptability and perceived usefulness.
|
Immediately after completion of the seven-day intervention (T1).
|
|
Blinded Objective Transfer Composite
기간: End of the seventh week of surgical clinical practice (T3).
|
Objective transfer at T3 was assessed using three independently administered performance tasks: an Objective Structured Clinical Examination safety station, a transfer vignette containing scenarios not used in the intervention, and a standardized escalation task.
Each component was z-standardized across the full randomized sample and assigned equal weight.
The mean of the three standardized components was transformed as 50 + 10 x mean(z).
Higher scores indicate better objective transfer of patient-safety learning.
Supervisor ratings were not included in this composite.
|
End of the seventh week of surgical clinical practice (T3).
|
|
EMA Behavioral Transfer Index
기간: Weekly during surgical clinical practice, weeks 1 through 7.
|
Safety-oriented behavioral transfer during surgical clinical practice was assessed using one ecological momentary assessment prompt at the end of each scheduled clinical practice day.
The index comprised three binary actions: noticing a patient-safety risk, making an appropriate response, and escalating or discussing the concern with a supervisor.
The index was calculated as the mean of the three binary actions multiplied by 100, producing a score from 0 to 100.
Higher scores indicate stronger safety-oriented behavioral transfer.
EMA confidence, stress, reflective depth, and the contemporaneous note were separate contextual items and were not included in the index.
Free-text notes were not used in quantitative group-effect estimates or interview-derived qualitative themes.
Potentially identifying patient information was removed during data cleaning and was not retained in the analytical dataset.
|
Weekly during surgical clinical practice, weeks 1 through 7.
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Intervention Fidelity
기간: Throughout the seven-day intervention and summarized immediately after intervention completion (T1).
|
Intervention fidelity was assessed from platform-recorded module completion (0-7 modules), completion percentage (0-100%), total time on task in minutes, retrieval-question accuracy (0-100%), proportion of corrective feedback viewed (0-100%), reminder-opening percentage (0-100%), and platform uptime (0-100%).
These measures described exposure and delivery fidelity and were not interpreted as clinical outcomes.
|
Throughout the seven-day intervention and summarized immediately after intervention completion (T1).
|
|
Unintended Effects and Access Burdens
기간: Weekly during surgical clinical practice, weeks 1 through 7, and at the end of the seventh clinical week (T3).
|
Unintended effects and access burdens were prospectively elicited through weekly study prompts and a T3 assessment.
Each report was coded by event category (notification fatigue, temporary pre-placement anxiety, technical access frustration, minor extra stress, or data/connectivity barrier), severity, relatedness, action taken, resolution, and whether it led to discontinuation.
The outcome was summarized for each arm as the number of event reports by category and the number and percentage of participants reporting at least one event.
This was a count-based outcome, not a scale; no composite score or score range was used, and lower counts indicated fewer reported burdens.
Reports included both intervention-related experiences and burdens arising from the study's ecological momentary assessment and reminder procedures.
Notification or access reports in the control arm were not attributed to digital microlearning exposure.
|
Weekly during surgical clinical practice, weeks 1 through 7, and at the end of the seventh clinical week (T3).
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- World Health Organization. Patient safety curriculum guide: Multi-professional edition. Geneva: WHO; 2011.
- Lee SE, Morse BL, Kim NW. Patient safety educational interventions: A systematic review with recommendations for nurse educators. Nurs Open. 2022 Jul;9(4):1967-1979. doi: 10.1002/nop2.955. Epub 2021 May 28.
- De Gagne JC, Park HK, Hall K, Woodward A, Yamane S, Kim SS. Microlearning in Health Professions Education: Scoping Review. JMIR Med Educ. 2019 Jul 23;5(2):e13997. doi: 10.2196/13997.
- Hopewell S, Chan AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials. BMJ. 2025 Apr 14;389:e081124. doi: 10.1136/bmj-2024-081124.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
- Digital Microlearning-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .