臨床研究護理師職場「可信賴專業活動」模式之建置

Abstract

【背景】臨床研究護理師（Clinical Research Nurse ，CRN）的專業角色，屬「進階護理師」層級，但台灣臨床試驗（或研究）機構缺乏培養CRN能力及分級制度，有礙專業的發展，因此擬參考醫學教育已導入職場可信賴專業活動（Entrsutable Professional Activity, EPAs），發展CRN之EPAs，作為試驗（或研究）機構之參考。【目的】(一)探討目前國內資深CRN職涯轉換的成長歷程與經驗；(二)訂定國內CRN 職場 EPAs及職能內涵與品質之評量；(三)制定出EPAs職場可應用模式~以CRN I EPAs評量表為例。【方法】以量性研究法為主，訪談法為輔。採三階段設計，第一階段訪談七位超過七年以上臨床試驗（或研究）的CRN，將「CRN職涯轉換的成長歷程與經驗」以內容分析法萃取主要主題；第二階段以修正式德爾菲法進行四回合，共有19位臨床試驗實務經驗及了解CRN工作內容之專家，自擬「臨床研究護理師EPAs架構共識」問卷與線上會議；第三階段進行EPAs架構之「台灣中文版EQual品質量表」，共6位專家採二次、間隔三周評量。 【結果】研究結果分為（一）訪談結果依內容分析萃取出四大主要主題：1）適應工作與職位；2）培養可信賴特質；3）表現獨立自主性；4）教與學的經驗；（二）修正式德爾菲法共識，訂定岀：1) 13個EPAs主題，分成8個基礎型與5個特殊情況型EPAs，其工作描述各有49、31項，2) CRN的八大核心能力對應到13個EPAs時，顯示「臨床研究實務」和「管理與領導」核心能力皆在全部EPAs主題中需要；3)規劃出CRN之EPAs進展架構藍圖，顯示13個EPAs架構可涵蓋從CRN I到CRN III能力分級層面，另外再進行CRN IV、CRN V自擬之EPAs主題；4)訂定出CRN I~CRN III層級可獨立執行之EPAs數目，分別為4、6及3個，並規劃出每個EPAs架構；（三）測量13個EPAs之EQual品質，顯示具評量者內在一致性與「臨床研究護理師EPAs架構共識」問卷信度為0.7以上。【結論與建議】訂定出13個EPAs主題，皆有對應之核心能力，可應用於CRN I~CRN III之能力分級階段；進而規劃出CRN I~CRN III之EPAs進展架構藍圖與另擬CRN IV與CRN V之EPAs主題共17個EPAs；EPAs架構品質問卷具評量者內在一致性與「臨床研究護理師EPAs架構共識」問卷信度。建議臨床試驗（或研究）機構，可導入EPAs架構於完善CRN教、考，訓、用制度與政策參考。

Background: The professional role of Clinical Research Nurses (CRNs) is categorized as an advanced nursing specialty, both nationally and internationally. However, the absence of a structured system for nurturing and classifying CRNs within clinical trial organizations in Taiwan poses significant obstacles to their professional development. In response to this deficiency, this study seeks to leverage the concept of Entrustable Professional Activities (EPAs) introduced in medical education to formulate EPAs for CRNs, providing a foundation for reference within clinical trial organizations. Objective: (1) To explore the career transition process and experiences of senior CRNs in Taiwan. (2) To develop a framework for CRN workplace EPAs and assess their content and quality. (3) To establish a model for applying EPAs in the workplace, using CRN I EPAs as an example. Methods: The research primarily adopts a quantitative approach, complemented by qualitative interviews, and comprises three distinct phases. The first phase involves interviews with seven CRNs with over seven years of clinical trial experience, with the aim of using content analysis to extract primary themes related to career transition and experiences. The second phase employs a modified Delphi method, incorporating four rounds of consensus-building with 19 experts who possess substantial experience in clinical trial practice and a comprehensive understanding of CRN roles. They actively participate in the development of a questionnaire titled "CRN EPA Framework Consensus" and engage in online meetings. In the third phase, the "Taiwanese version of the EQual Quality Assessment Scale" is applied to evaluate the quality of the EPA framework. Six experts assess the framework twice, with a three-week interval between assessments. Results: The study yields three key outcomes: (1) Findings from the interviews lead to the extraction of four main themes: (i) Adapting to the job and role, (ii) Cultivating trustworthy qualities, (iii) Demonstrating independence, and (iv) Teaching and learning experiences. (2) The modified Delphi method results in the formulation of: (i) 13 EPA themes, categorized into eight foundational and five specialized types, each comprising 49 and 31 job-specific descriptions, respectively, (ii) Alignment of eight core CRN competencies with the 13 EPA themes, highlighting the critical role of "Clinical Research Practice" and "Management and Leadership," and (iii) A blueprint outlining the progression of CRN EPAs, demonstrating the applicability of the 13 EPA themes across CRN I to CRN III skill levels, with CRN IV and CRN V also proposing self-generated EPA themes. (3) Assessment of the quality of the 13 EPAs using the EQual Quality Assessment Scale indicates high internal consistency among evaluators and questionnaire reliability exceeding 0.7 for the "CRN EPA Framework Consensus" questionnaire. Conclusion and Recommendations: The establishment of 13 EPA themes, each aligned with corresponding core competencies, offers applicability across CRN levels I to III. Further planning encompasses the development of a CRN EPA progression blueprint, including 17 EPAs, accommodating CRN IV and CRN V. Additionally, the EPAs framework quality assessment indicates favorable internal consistency and questionnaire reliability. It is recommended that clinical trial organizations consider implementing the EPA framework as a reference point for enhancing CRN education, evaluation, training, and employment policies and systems.