デジタルマイクロラーニングと看護学生における患者安全 (DigiM-2026)
手術前臨床実習前の看護学生におけるデジタルマイクロラーニングが患者安全意識と臨床意思決定に与える影響:無作為化比較試験
この無作為化比較試験は、看護学生が外科臨床実習を開始する前に、患者安全に焦点を当てたデジタルマイクロラーニングプログラムの効果を評価することを目的としています。
看護学生は、教室での学習から臨床現場への移行期において、患者安全と臨床意思決定に関連する課題に直面することが多いです。 この研究では、短く構造化されたデジタル学習モジュールが、患者安全意識、臨床エラーの認識、および意思決定スキルを向上させることができるかどうかを検証します。
2年次の看護学部生は、デジタルマイクロラーニング介入群と、標準的な教育を受ける対照群のいずれかに無作為に割り付けられます。 結果は、介入前、介入直後、および臨床実習の最初の週に測定されます。
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
看護学生における患者安全にとって、基礎教育から臨床実践への移行は重要な時期です。 この段階では、限られた臨床経験と増大する責任が組み合わさることで、患者安全や臨床判断に関連するエラーのリスクが高まる可能性があります。 したがって、臨床実習前に患者安全意識と認知的準備を強化する教育戦略が不可欠です。
本研究は、単施設、並行群、無作為化比較試験として設計されています。 アーリ・イブラヒム・チェチェン大学健康科学部看護学科で実施されます。 参加者は、初めて外科臨床実習を開始する準備をしている2年生の看護学士課程学生で構成されます。
ベースライン評価後、適格な参加者は性別と成績平均点に基づく層別無作為化を用いて、介入群または対照群のいずれかに無作為に割り付けられます。 介入群は、患者安全に焦点を当てたデジタルマイクロラーニングプログラムをオンラインで7日間連続して受講します。 このプログラムは、各約3〜5分の短いシナリオベースのモジュールで構成され、患者安全リスク、臨床エラー認識、優先順位付け、ストレス下での意思決定などのトピックを扱います。 参加者は、毎日の時間制限内で柔軟にモジュールにアクセスできます。
対照群は、追加の介入なしで、看護学士課程カリキュラムの一部として標準的な患者安全教育を受けます。
アウトカム指標は、介入前のベースライン(T0)、介入完了直後(T1)、外科臨床実習の最初の週(T2)の3時点で収集されます。 主要アウトカムには、患者安全意識と臨床エラー認識パフォーマンスの変化が含まれます。 副次アウトカムには、ストレス下での臨床意思決定、臨床実習に対する認識された準備度、自信、デジタルマイクロラーニングプログラムの受容性が含まれます。
本研究は教育介入のみを含み、侵襲的処置、薬剤、医療機器は含みません。 参加は自発的であり、すべての参加者から書面によるインフォームドコンセントを取得します。 本研究は倫理審査に提出されており、ヒトを対象とする研究の倫理原則に従って実施されます。
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前:VOLKAN GOKMEN, Assistant Professor
- 電話番号:+905327390938
- メール:vgokmen@agri.edu.tr
研究場所
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Merkez
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AĞRI、Merkez、トルコ(Türkiye)、04100
- Agri Ibrahim Cecen University Faculty of Health Sciences
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参加基準
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
適格基準:
- 看護学部2年生
- 保健科学部看護学科に在籍していること
- 初めて外科臨床実習を開始する予定であること
- 18歳以上であること
- 参加に同意し、文面によるインフォームドコンセントを提供できること
除外基準:
- 過去に外科臨床実習の経験がある
- 過去に専門的な看護または医療業務の経験がある
- ベースライン評価が不完全である
- 参加を辞退する、または同意を取り下げる
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:ヘルスサービス研究
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
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実験的:Digital Microlearning Intervention Group
Participants received a seven-day patient-safety-focused digital microlearning program in addition to standard education before surgical clinical practice.
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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.
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介入なし: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.
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この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Clinical Error Recognition Performance at Clinical Week 7 (T3)
時間枠: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).
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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.
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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).
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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Clinical Decision-Making Under Stress
時間枠: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).
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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.
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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).
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Patient Safety Awareness
時間枠: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).
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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.
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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).
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Clinical Practice Readiness
時間枠: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).
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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.
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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).
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Clinical Self-Confidence
時間枠: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).
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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.
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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).
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Acceptability of the Digital Microlearning Program
時間枠:Immediately after completion of the seven-day intervention (T1).
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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.
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Immediately after completion of the seven-day intervention (T1).
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Blinded Objective Transfer Composite
時間枠:End of the seventh week of surgical clinical practice (T3).
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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.
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End of the seventh week of surgical clinical practice (T3).
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EMA Behavioral Transfer Index
時間枠:Weekly during surgical clinical practice, weeks 1 through 7.
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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.
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Weekly during surgical clinical practice, weeks 1 through 7.
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その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Intervention Fidelity
時間枠:Throughout the seven-day intervention and summarized immediately after intervention completion (T1).
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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.
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Throughout the seven-day intervention and summarized immediately after intervention completion (T1).
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Unintended Effects and Access Burdens
時間枠:Weekly during surgical clinical practice, weeks 1 through 7, and at the end of the seventh clinical week (T3).
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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.
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Weekly during surgical clinical practice, weeks 1 through 7, and at the end of the seventh clinical week (T3).
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協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
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
その他の研究ID番号
- Digital Microlearning-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。