Müller Nicole, Gschwendtner Kathrin M, Dwinger Sarah, Bergelt Corinna, Eich Wolfgang, Härter Martin, Bieber Christiane
Department of General Internal Medicine and Psychosomatics, Center for Psychosocial Medicine, Heidelberg University Hospital, Thibautstraße 4, 69115, Heidelberg, Germany.
Department of Medical Psychology, Center for Psychosocial Medicine, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany.
Trials. 2019 Jan 7;20(1):18. doi: 10.1186/s13063-018-3112-7.
Oncological patients often feel left out of important treatment decisions. However, when physicians engage them in shared decision-making (SDM), patients benefit in many ways and the situation is improved. SDM can effectively be taught to physicians, but participation barriers for SDM physician group trainings are high, making it hard to convince physicians to participate. With this in mind, we aim to develop and evaluate two new dissemination strategies for a brief, SDM training program based upon a proven SDM group-training concept: an individualized context-based SDM face-to-face training (IG I) and a web-based interactive SDM online training (IG II). We aim to analyze which improvements can be achieved by IG I and II compared to a control group (CG) in physician SDM competence and performance as well as the impact on the physician-patient relationship. Furthermore, we analyze differences in satisfaction concerning the two dissemination strategies by means of a training evaluation.
METHODS/DESIGN: We examine - based on a three-armed randomized controlled trial (IG I, IG II, CG) - the effectiveness of two new dissemination strategies for a SDM training program compared to a CG receiving no SDM training (voluntary access to SDM training as an incentive for participation after completion of the study). We aim to include 162 physicians randomized to one of the three arms. There will be two assessment points in time (before intervention: T and post-training: T). The main outcome is the SDM competence of physicians as measured by an established observational assessment rating system (OPTION-12) by means of consultations with Standardized Patients. Standardized Patients are individuals trained to act as "real" patients. Secondary outcome measures are the SDM performance (SDM-Q-9) and the Questionnaire on the Quality of Physician-Patient-Interaction (QQPPI) both rated by Standardized Patients as well as the physicians' training evaluation.
This trial will assess the effectiveness and acceptability of two new dissemination strategies for a brief, SDM training program for physicians. Opportunities and challenges regarding implementation in daily routines will be discussed.
ClinicalTrials.gov, Identifier: NCT02674360 . Prospectively registered on 4 February 2016.
肿瘤患者常常感觉自己被排除在重要的治疗决策之外。然而，当医生让他们参与共同决策（SDM）时，患者会在许多方面受益，情况也会得到改善。可以有效地向医生传授共同决策，但共同决策医生小组培训的参与障碍很高，很难说服医生参与。考虑到这一点，我们旨在基于经过验证的共同决策小组培训概念，开发并评估两种新的传播策略，用于一个简短的共同决策培训项目：基于个性化情境的共同决策面对面培训（干预组I）和基于网络的交互式共同决策在线培训（干预组II）。我们旨在分析与对照组（CG）相比，干预组I和II在医生共同决策能力和表现方面能够实现哪些改进，以及对医患关系的影响。此外，我们通过培训评估分析两种传播策略在满意度方面的差异。
方法/设计：我们基于一项三臂随机对照试验（干预组I、干预组II、对照组），研究与未接受共同决策培训的对照组相比（研究完成后，以自愿参加共同决策培训作为参与激励），共同决策培训项目的两种新传播策略的有效性。我们的目标是纳入162名随机分配到三个组之一的医生。将有两个评估时间点（干预前：T0和培训后：T1）。主要结果是通过既定的观察性评估评级系统（OPTION-12），借助与标准化患者的会诊来衡量医生的共同决策能力。标准化患者是经过培训以扮演“真实”患者的个体。次要结果指标包括标准化患者评定的共同决策表现（SDM-Q-9）和医患互动质量问卷（QQPPI），以及医生的培训评估。
本试验将评估针对医生的简短共同决策培训项目的两种新传播策略的有效性和可接受性。将讨论在日常工作中实施的机会和挑战。
ClinicalTrials.gov标识符：NCT02674360。于2016年2月4日前瞻性注册。
