臨床研究護理師性格特質及身心健康與專業角色職責自我效能之相關

Abstract

【背景】臨床試驗帶領人類健康福祉精進，有臨床試驗確立新療效，後人可享先進的醫療成果。衛生福利部統計顯示臺灣臨床試驗申請數量自93年的119件，至106年已增為298件，亦持續成長中。隨著臨床試驗案增加，臨床研究護理師(clinical research nurse, CRN)角色功能益形重要，研究支持CRN正是決定臨床試驗品質的關鍵人物，探討其專業角色職責的重要性與日俱增。自我效能信念影響個體的行動選擇、投入活動的努力程度、在遭遇困難和失敗經驗時的堅持力及從失敗復原的動力，被視為是人類行為動機、心理健康和個人成就的基礎，與專業角色職責的執行度與品質息息相關，而自我效能容易受個體自身性格特質及身心狀態所影響，目前尚無針對CRN角色職責自我效能之本土相關研究，本研究期望了解CRN角色職責自我效能與性格特質和身心健康的相關性。本研究目的為先比較CRN與臨床護理師(registered nurses, RN)在背景特徵、身心健康及性特質有無差異，再探討上述因素對臨床研究護理師角色職責的自我效能之相關性。 【方法】研究設計為橫斷式研究，利用紙本及電子問卷兩種形式收集資料，問卷內容包含基本背景資料、臨床研究護理師專業職責之自我效能、身心健康與性格特質，採用不記名問卷，以滾雪球方式於醫院、受託研究機構(Contract Research Organization ,CRO)、試驗機構管理組織(Site Management Organization ,SMO)及藥廠進行收案。 【結果】本研究共納入134位CRN與104位RN，CRN年齡較高(約年長五歲)、學歷較高(研究所畢業較多)、已婚較多，臨床試驗資歷較豐富(平均五年資歷，目前七成以上參與四件以上的臨床試驗案件)。CRN自覺睡眠品質與生活品質較佳；CRN組及RN組，未來一年離職異動可能性並無差異，未來一年換機構但維持原來工作類型者其可能性約40%，而同機構換部門或離開護理專業可能性約20%。身心健康狀況不佳的比例CRN組為50.8%，與RN組65.4%有顯著不同；兩組的外向特質並無顯著差異，但神經質特質(neuroticism)則是RN組較CRN組高，且達統計顯著差異(獨立T檢定=2.478, p=0.014)。臨床研究護理師(CRN)自評角色職責自我效能的四個部分，自我效能較高的是「受試者保護」(平均2.77±0.67)與「受試者臨床照護」(平均2.77±0.65)，而「研究協調與管理」其次(平均2.75±0.67)，自我效能最低的是「進階護理職能」(平均2.09±0.76)。以逐步多變項羅吉斯迴歸檢視CRN高自我效能的相關因素，發現高臨床試驗年資(adjusted Odd Ratio (aOR)=4.13，95%CI=1.89-9.02)以及自覺近兩週睡眠品質高 (aOR=3.04，95%CI=1.40-6.61)以及離開原機構，但仍從事類似工作可能性高(aOR=2.83，95%CI=1.30-6.14)為重要相關因素；若以線性迴歸檢視CRN高整體自我效能的相關因素，則是臨床試驗年資(β=2.292, p<0.001)、教育程度(β=9.112, p=0.021)、常見精神疾病症狀(β=-2.249, p=0.016)以及離開護理工作可能高(β=0.150, p=0.029)共四個變項為重要相關因素。 【結論】相較於臨床護理師，臨床研究護理師年齡較長、學歷研究所畢業較多、已婚較多、自覺睡眠品質與生活品質較佳、身心健康狀況較佳、神經質特質(neuroticism)較低；CRN專業角色職責自我效能上需要更多教育訓練或成長機會，以利提升CRN對自我的工作效能評價，且應持續維持CRN好的睡眠品質與專業自我效能的正相關性，CRN工作穩定性及產業異動選擇性高亦與CRN高自我效能甚為相關。

Background Clinical trials establish the effectiveness of new treatment for diseases to enrich human’s well-being. According to the Ministry of Health and Welfare’s annual reports, the number of clinical trials in Taiwan has increased from 119 in 2004 to 298 in 2017 and the figures are still increasing. Previous studies have proved clinical research nurses (CRNs) play a vital and active role in excellence and the quality of clinical trials. To understand the professional role performance and responsibility increases its importance. Self-efficacy is highly associated with work performance and quality of professional role because it can impact on people’s motivation, perseverance, and resilience. Self-efficacy has been identified as the foundation of behavioral motivation, psychological well-being, and personal achievement as well as the key of professional executives and quality of performance. Self-efficacy, however, can be affected by one’s personality traits and physical and mental health status. There is limited information regarding the CRNs’ self-efficacy of professional roles and performance in Taiwan. This research aimed to (1) compare background characteristics, personality trait, mental health between CRNs and Registered Nurses (RNs); and (2) explore the associations among self-efficacy of professional role and performance, personality traits, mental health status, and background characteristics. Method A cross-sectional study with snowball sampling was conducted in hospitals, contract research organization, site management organization, and pharmapeutical company in Taiwan. The CRNs and RNs were asked to complete either hard-copy or electronic questionnaire anonymously. This structured questionnaire comprised the role responsibilities of CRNs, Chinese Health Questionnaire, Eysenck Personality Questionnaire-Revised Short, and background information. Results A total of 134 CRNs and 104 RNs were recruited. The CRNs were 5 years older and more married, and higher educated than their RNs counterparts. CRNs were experienced in clinical trials with averaged 5.3 years experiences, 70% involving in 4 or more trials. The CRNs’ reported to have higher quality of sleep and life than did RNs. There is no significant difference between two groups in their resignation in the coming year. For both groups, the possibility of transferring to other institute with the same job type was about 40% and the possibility of changing departments in the same institute or leaving nursing profession were all around 20%. There was 50.8% in CRNs and 65.4% in RNs not to be considered as mentally well-being. As for the personality, there was also a significant difference in neuroticism between CRNs (score=4.6±3.1) and RNs (score=5.6±3.3) (T-test=2.478, p=.014) but not in extraversion. The CRNs rated their self-efficacy on professional role and performance: protection of study subjects (2.77±0.67), clinical care of study subjects (2.77±0.65), coordination and management of clinical trials (2.75±0.67), advanced nursing competency (2.09±0.76). We further analyzed the factors related to high self-efficacy in the CRNs by using stepwise multiple logistic regression. The results indicated the experiences of involving in the clinical trials (adjusted Odd Ratio (aOR)=4.13，95%CI=1.89-9.02), perceived quality of sleep in past two weeks (aOR=3.04，95%CI=1.40-6.61), high possibility of transferring to new institute with same work type (aOR=2.83，95%CI=1.30-6.14) were 3 significant factors. On the other hand, by using multivariate stepwise linear regression analysis found experiences of involving in the clinical trials(β=2.292, p<0.001), educational level(β=9.112, p=0.021), common mental disorder(β=-2.249, p=0.016), and the possibility of leaving nursing profession (β=0.150, p=0.029) were significant factors related to the CRN’s high self-efficacy. Conclusion Overall, this research results showed the CRNs were older, more married, with higher education, better quality of sleep and life, less mental symptoms, and lower neuroticism trait than their RNs counterparts. In order to enhance CRNs’ self-efficacy of professional role and work performance, more professional training and educational opportunities are required. Furthermore, it is suggested to continually improve sleep quality, work stability and promotion opportunity for CRNs.