以混合研究法探討臨床研究護理師專業角色轉任歷程

Abstract

背景：臨床研究護理師主要角色為協助醫藥試驗研究之執行，並關注受試者之照護及安全，是護理進階角色功能的展現，但研究護理師轉任歷程多元，因此轉任後面臨新角色壓力、適應困難或甚至產生職業倦怠。臨床試驗執行中心之設置漸趨普及，民眾接觸臨床試驗或受邀參加臨床試驗的機會持續增加，於第一線照護受試者並協助臨床試驗進行的臨床研究護理師之角色功能更顯重要。臺灣醫療的成就受到國際肯定，榮耀的背後是許多醫護人員的奉獻，因而衍伸出醫療環境職業倦怠議題。造成職業倦怠因素複雜，可包含工作過度負荷、時間壓力、角色不明確、角色衝突、缺乏社會支持及對工作的低掌控度等，長期的職業倦怠會影響工作者的察覺能力，甚至產生不滿、焦慮、憤怒、憂鬱等情緒，因此針對臨床研究護理師之轉任歷程的探討成為至關重要的議題，值得採用多元的角度來理解。

方法：本研究採用混合研究法（mixed-method approach），採用量性自填問卷及質性訪談雙軌收集資料，以增加資料的多元見解與豐富性。研究問卷包含個人背景與經歷、研究護理師壓力源量表、職場疲勞量表、憂鬱量表及職業倦怠（Burnout）評估量表。一對一質性訪談則運用訪談大綱指引收集資料，主題包含轉任歷程與心境、於試驗團隊中角色職責、面臨倫理困境經驗及未來發展與職涯規劃。量性資料以多元羅吉斯迴歸探討職業倦怠的相關因素。訪談錄音檔以主題分析法歸納研究主題有關的經驗意義，透過質性訪談資料提供多元觀點，豐富研究結果。

結果：本研究納入183位臨床研究護理師，其中14位接受一對一深度訪談。根據職業倦怠量表自述，樣本中有25.1%（n=46）出現職業倦怠情形，於多元逐步羅吉斯迴歸模型中發現與職業倦怠相關因素包含「工作經驗中最常執行Phase 3試驗」（adjusted odds ratio, [aOR] =8.703, 95% confidence interval, [95% CI] =2.466-30.710），其餘亦增加研究護理師職業倦怠的因素還有：「模糊不清的工作項目」（aOR=1.165, 95% CI=1.013-1.340）、「目前手上負責或協助執行之臨床試驗案件數五件或以上」（aOR=3.427, 95% CI=1.086-10.813）、「過去二週感到心情低落沮喪或絕望」（aOR=2.700, 95% CI=.954-7.645）及「高度職場疲勞」（aOR=1.117, 95% CI=1.023-1.220）等；但同一模型中降低職業倦怠的因素有「臨床護理師工作年資深」（aOR=.671, 95% CI=.469-.961）及「未來一年繼續擔任CRN機率84%或更高」（aOR=.118, 95% CI=.038-.363）。質性訪談主要發現臨床研究護理師職責廣泛，除需保護受試者權益與安全外，還需解決試驗研究許多突發狀況與問題，其工作負荷大，因此受訪者建議轉任臨床研究護理師應接受專業培訓，以確保勝任能力，培訓面向可包含：溝通協調能力、組織管理能力、法律倫理原則、執業須謹慎具獨立能力、終生學習等。

結論：本研究結果顯示臨床研究護理師職業倦怠與工作資歷經歷、工作壓力、職場疲勞、憂鬱等均具相關性，臨床研究護理師於受訪時，表示薪資福利與期待不符、人力配置不足以致工作壓力大且職責廣泛，認為目前執業環境偏負向，建議臨床研究護理師之職業倦怠議題應受重視，未來臨床試驗機構當設置相應的管理單位，主責為CRN提供完善的培訓與陞遷管道，並保障工作的權益，增加轉任臨床研究護理師之意願，並提高續任機率，避免人力短缺或重複培訓新手，使得專業提升面臨困難，也能提高受試者之照護品質及提升臨床試驗執行之安全與成效。

Background: The main role of clinical research nurses is to assist in the execution of clinical trials and pay attention to the care and safety of the study participants, which is the manifestation of advanced practice nursing. However, the clinical research nurses' transition journeys is diverse, so they face the pressure of new roles, difficult adaptation or burnout. With the increasing popularity of clinical trial centers increasing opportunities for the public to access clinical trials or be invited to participate in clinical trials, the role of clinical research nurses in the frontline care of study participants and assisting in the conduct of clinical trials has become more crucial. Taiwan's medical achievements have been internationally recognized, and behind the glory is the dedication of many healthcare staff, which has led to the issue of burnout in the medical environment. Burnout factors are complex and can include overwork, time pressure, unclear roles, role conflicts, lack of social support, and low control over work. Long-term burnout can affect workers' ability to perceive, and even produce emotions such as dissatisfaction, anxiety, anger, and depression. Therefore, the discussion of the transition process of clinical research nurses has become a crucial topic that deserves to be understood from multiple perspectives.

Method: This study uses a mixed-method approach, combining quantitative self-administered questionnaires and qualitative one-on-one interviews, to gather diverse insights and enrich the findings. The research questionnaire includes sections on personal background and experiences, the Stressor Scale for Clinical Research Coordinator (SSCRC), workplace fatigue scale, the Patient Health Questionnaire-2 (PHQ-2) for assessing depressive symptoms, and a Burnout assessment scale. Individual qualitative interviews are conducted using interview guides to collect data on topics such as the transition process and mindset, role responsibilities within the research team, experiences of ethical dilemmas in practice, and future development and career planning. The quantitative data are analyzed by multivariate logistic regression to explore factors related to professional burnout. The interview recordings are analyzed using thematic analysis to synthesize relevant meanings and provide diverse perspectives to enrich the research findings.

Results: This study included a total of 183 clinical research nurses, with 14 of them participating in qualitative one-on-one in-depth interviews. According to the Chinese version of the Occupational Burnout Scale, it was found that 25.1% (n=46) of the clinical research nurses experienced occupational burnout. Factors associated with occupational burnout included the most frequent involvement in Phase 3 trials during their professional experience, which had the greatest impact on burnout (adjusted odds ratio [aOR] =8.703, 95% confidence interval [95%CI] =2.466-30.710). Other factors that increased the likelihood of occupational burnout among research nurses included "unclear job responsibilities" (aOR=1.165, 95% CI=1.013-1.340), "currently responsible for or assisting in the execution of five or more clinical trial cases" (aOR=3.427, 95% CI=1.086-10.813), "feeling down, depressed, or hopeless in the past two weeks" (aOR=2.700, 95% CI=.954-7.645), and "high levels of workplace fatigue" (aOR=1.117, 95% CI=1.023- 1.220). However, "more years of clinical nursing experience" (aOR=0.671, 95% CI=.469 -.961) and "probability of continuing as a clinical research nurse (CRN) for 84% or more in the next year" (aOR=.118, 95% CI=.038-.363) were associated with lower levels of occupational burnout. The qualitative interviews primarily revealed that clinical research nurses have broad responsibilities, including protecting the rights and safety of participants and addressing various unexpected situations and issues in research trials, leading to a high workload. Therefore, participants suggested that clinical research nurses should receive professional training to ensure competence. The training could focus on communication and coordination skills, organizational management abilities, legal and ethical principles, the need for cautious and independent practice, and lifelong learning.

Conclusion: The results of this study indicate that professional burnout among clinical research nurses is associated with higher levels of job experience, work pressure, workplace fatigue, and depression. During the interviews, clinical research nurses expressed that the salary and benefits needed to meet their expectations, and the lack of staffing led to high work pressure and extensive responsibilities. They perceived the current practice environment as unfriendly. Therefore, the issue of professional burnout among clinical research nurses should be given attention. In the future, clinical trial institutions should establish dedicated management units responsible for providing comprehensive training and career advancement opportunities for CRNs, ensuring job rights and benefits, increasing the willingness to transition to clinical research nursing, and improving the likelihood of retention. This would help avoid manpower shortages or repetitive training of newcomers, which can pose difficulties in professional advancement. Furthermore, it would enhance the quality of care for trial participants and improve the safety and effectiveness of clinical trial execution.