多专业团队沟通技巧培训在肿瘤学中的效果：一项三臂整群随机对照试验的研究方案（KommRhein Interpro）。
Effectiveness of interprofessional communication skills training for oncology teams: study protocol for a three-arm cluster randomised trial (KommRhein Interpro).
机构信息
Institute for Psychosomatic Medicine and Psychotherapy, University Hospital Düsseldorf, Medical Faculty, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany
Department of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Center for Integrated Oncology Aachen, RWTH Aachen University, Medical Faculty and University Hospital, Aachen, Germany.
出版信息
BMJ Open. 2022 Dec 29;12(12):e062073. doi: 10.1136/bmjopen-2022-062073.
INTRODUCTION
Patient-provider communication is an important factor influencing the quality of care in oncology. The study examines the comparative effectiveness of a 10-hour interprofessional communication skills training (CST) programme for physicians and nurses in cancer centres.
METHODS AND ANALYSIS
KommRhein Interpro is a cluster-randomised trial sponsored by the German Cancer Aid (Deutsche Krebshilfe, DKH) and conducted at the cancer centres of the university hospitals of Aachen, Bonn, Cologne and Düsseldorf. Thirty oncology teams of four cancer centres are randomly assigned to three study arms, providing healthcare professionals with either (a) only written information on patient-centred communication or (b) written information plus CST for physicians or (c) written information plus interprofessional CST for physicians and nurses. For summative evaluation, standardised surveys from three measurement points for patients (T0pat: study enrollment; T1pat: after discharge; T2pat: 3 months' follow-up) and two measurement points for physicians and nurses (T0hcp: before the intervention; T1hcp: after the intervention) are used. N=1320 valid patient cases are needed for data evaluation. The primary endpoint is fear of progression in patients with cancer after discharge. Data will be analysed according to the intention-to-treat principle using a mixed model for repeated measurement. Secondary outcome is the providers' self-efficacy in patient centeredness. Individual confounders and possible moderating effects of organisational factors will be considered. Secondary analysis will be performed by means of multilevel analysis and structural equation modelling.
ETHICS AND DISSEMINATION
A vote of approval has been obtained from the ethics committees of the medical faculties of RWTH Aachen University (EK325/20), University of Bonn (391/20), University of Cologne (20-1332) and Heinrich Heine University Düsseldorf (2019-796). Data protection regulations are adhered to for all processed data. The conduct of the study will be monitored. Dissemination strategies include a transfer workshop with cancer teams and distribution of the final study report to participants.
TRIAL REGISTRATION NUMBER
DRKS00022563; DRKS (German Clinical Trials Register).
简介
医患沟通是影响肿瘤学治疗质量的一个重要因素。本研究考察了一种针对癌症中心医生和护士的 10 小时跨专业沟通技巧培训（CST）项目的比较效果。
方法与分析
KommRhein Interpro 是一项由德国癌症援助组织（Deutsche Krebshilfe，DKH）赞助的、在亚琛、波恩、科隆和杜塞尔多夫大学医院的癌症中心进行的集群随机试验。30 个肿瘤团队随机分配到三个研究组，为医护人员提供（a）以患者为中心的沟通的书面信息，或（b）书面信息加医生 CST，或（c）书面信息加医生和护士的跨专业 CST。为了总结性评估，使用来自三个测量点的患者标准化调查问卷（T0pat：研究入组；T1pat：出院后；T2pat：3 个月随访）和两个测量点的医生和护士调查问卷（T0hcp：干预前；T1hcp：干预后）。需要 1320 个有效患者病例进行数据分析。主要终点是癌症患者出院后对病情进展的恐惧。数据将根据意向治疗原则使用重复测量混合模型进行分析。次要结果是提供者在以患者为中心方面的自我效能感。将考虑个体混杂因素和组织因素的可能调节作用。将通过多层次分析和结构方程模型进行二次分析。
伦理与传播
RWTH 亚琛大学医学系（EK325/20）、波恩大学（391/20）、科隆大学（20-1332）和杜塞尔多夫海因里希·海涅大学（2019-796）的伦理委员会已批准该研究。所有处理的数据均符合数据保护法规。研究的进行将受到监测。传播策略包括与癌症团队的转移研讨会和向参与者分发最终研究报告。
注册号
DRKS00022563；DRKS（德国临床试验注册处）。
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