運用圖像遊戲式教學於藥物相關皮膚不良反應之護理教育

Abstract

背景:藥物相關皮膚不良反應（Cutaneous Adverse Drug Reactions, CADRs）的發生經常會造成患者身心負向影響，亦增加醫療或社會成本。臨床研究護理師（Clinical Research Nurses, CRNs）是推動臨床試驗的團隊核心人員，如在照護CADRs時，有專業能力評估皮膚反應，能使CADRs早期發現和及時正確處置，便能降低不良反應的嚴重度及持續時間，增加受試者用藥安全及生活品質，也提高臨床試驗品質。本研究以臨床常見四種CADRs（斑丘疹、蕁麻疹、濕疹及痤瘡樣皮疹）設計圖像式教材及遊戲化介入，探討是否透過圖像化遊戲教學可以提高CRNs照護CADRs的知識、態度與實務能力。 方法:本研究為隨機分派設計（Randomized Controlled Trial, RCT），納入的CRNs隨機分為對照組或介入組，兩組均先完成前測評估，之後觀賞10分鐘CADRs教學影片，然後介入組接受圖像式遊戲化教學，對照組自行閱讀紙本文字教材，隨後兩組均完成後測評估。自填問卷包含人口學資料、CADRs認知（Knowledge）、態度（Attitude）、實務（Practice）及活動滿意度（Satisfaction），資料分析是透過多元逐步線性迴歸分析與CRNs接受圖像式遊戲化教學成效（認知、態度、實務及滿意度）之相關因素。 結果:共納入88位CRNs，對照組與介入組各44位，全為女性，平均年齡38.07± 7.14歲，護理教育程度以大學畢業最多（71.6%），臨床試驗相關工作年資7.45 ± 5.71年。增加CRNs面對CADRs的認知之顯著相關因素，包含CRNs最高學歷為專科（ß=1.6883）、年齡<35歲（ß=1.0132）、臨床試驗研究年資介於4~14年（ß=.7185）、執行非婦科或非兒科之試驗（ß=2.1025）、近一年內曾執行Phase II臨床試驗案（ß=.4588）、近一年內照護CADRs者4人以上（ß=1.5161）、認為評估CADRs沒有困難者（ß=1.8379），以及面對CADRs無焦慮感者（ß=.5293）等，整體模型可解釋變異量為78 %（R2=.7825）。第二個成效為態度層面的改變，就是提高CRNs的自信度，遊戲化介入措施對CRNs自信度的提升成效相對較佳因素有：CRN本身執業科別為「腫瘤醫學科（ß=1.9884）」或「外科系（ß=1.8680）」且被分配至介入組、自認評估CADR困難度低者（ß=2.8827）、介入措施前自評「提供適切CADR自我照顧衛教的自信度」極低（ß=4.4205）或是低（ß=1.5816）者等，符合上述條件之CRN於本研究介入措施後，對CADR的自信度能較顯著提升。本研究之實務層面成效後測為CRN接受介入措施後，能提升CRN對CADR正向實務行動，相關要素有CRN年齡介29至42歲之間並接受遊戲式的介入措施（ß=5.4206）; 現階段職業非腫瘤相關、非內外科及非產兒科的其他科別者（ß=6.1081）; 認知前測答對多（ß=6.4556）;提供適切照顧衛教的自信度極低（ß=15.4416）者; 後測的自信度高者（ß=6.9385）等。研究顯示圖像遊戲式的教學介入措施能夠有效地提升學習者在「創新性（Innovation） （p< .0006）」及「創意性（Creativity） （p< .0005）」方面有正向的顯著表現，且CRN受試者之反饋亦顯示創新的教學模式值得進一步發展。 結論:本研究結果支持遊戲化教學介入對臨床研究護理師評估藥物相關皮膚不良反應有正向成效，教育介入能提升CRNs對CADRs認知、態度、實務能力，並增強其正向行動意向，且學習者滿意度高，可以提升創新性及創意性。

Background: Cutaneous Adverse Drug Reactions (CADRs) often cause negative physical and mental effects on patients and increase medical or social costs. Clinical Research Nurses (CRNs) constitute a pivotal group in drug trials, wielding expertise in evaluating skin toxicity. Their crucial role involves timely identification and appropriate management of CADRs, leading to a substantial reduction in adverse reaction severity and duration. This, in turn, enhances patient quality of life and upholds the quality of clinical trials and care, ensuring the safety of trial participants. In this study, four common CADRs (maculopapular rash, urticaria, eczema, and acneiform rash) were used to design image-based teaching materials and gamification interventions and explore whether the knowledge, attitude and practical ability of CRNs in caring for CADRs can be improved through image-based gamification teaching. Methods: This study employed a randomized controlled trial (RCT) design, involving Clinical Research Nurses (CRNs) who were randomly assigned to control and intervention groups. Both groups underwent pre-test assessments and viewed a 10-minute instructional video. The intervention group received image-based and gamified educational intervention, while the control group read paper-based textual materials. Subsequently, both groups completed post-test assessments using self-administered questionnaires to gather demographic data, CADRs knowledge, attitude, practice, and satisfaction. Multiple variable linear regression models were applied to explore the factors influencing the effectiveness of the intervention. Results: A total of 88 CRNs were included, 44 in the control group and 44 in the intervention group, all of whom were women, with an average age of 38.07± 7.14 years old, the most nursing education level (71.6%), and the clinical trial related work experience 7.45 ± 5.71 years. Significant correlation factors that increased CRNs' knowledge of CADRs included that the highest degree of CRNs was junior college (ß=1.6883), age < 35 years old (ß=1.0132), clinical trial research experience between 4~14 years (ß=.7185), working on non-gynecological or non-pediatric trials (ß=2.1025), conducting Phase II clinical trials (ß=.4588) within the past year, and caring for more than 4 participants for CADRs in the past one year (ß=1.5161), those who thought that there was no difficulty in assessing CADRs (ß=1.8379). Those who had no anxiety in the face of CADRs (ß=.5293), the overall model explained 78% variances (R2=.7825). The second effect is a change in attitude, that is, to improve the confidence of CRNs, and the factors that have relatively good results in enhancing the confidence of CRNs by gamification intervention are: CRNs from Oncology (ß=1.9884) or Surgery (ß =1.8680) departments and are assigned to the interventional group, those who think that the difficulty of assessing CADR is low (ß=2.8827), and "the confidence of providing appropriate CADR self-care and education" is extremely low (ß=4.4205) or low (ß=1.5816) at pre-assessment, CRN who met the above conditions could significantly improve their confidence in CADR after the intervention. The practical effect of this study was that CRN could improve the positive practical action, and the relevant factors included CRN age between 29 and 42 years old and receiving gamified education (ß=5.4206); working at non-oncology, non-medical-surgical, and non-obstetric-pediatrics-units (ß=6.1081); baseline knowledge is sufficient (ß=6.4556); Those with very low confidence in providing appropriate care and education (ß=15.4416); Those with high confidence in the post-test (ß=6.9385), etc. The study shows that the teaching intervention of image-based gamified education can effectively improve the positive performance of learners in "Innovation (p< .0006)" and "Creativity (p< .0005)", and the feedback of CRN participants also shows that innovative teaching models are worthy of further development. Conclusion: The results of this study support that gamified teaching interventions have positive effects on clinical research nurses in evaluating drug-related cutaneous adverse reactions (CADRs). The educational interventions can improve CRNs' cognition, attitude, and practical ability to manage CADRs, and enhance their positive action intentions, and high learner satisfaction can enhance innovation and creativity.