Randomized Controlled Trial Regarding (RCT) Innovative Dissemination Strategies for a Brief Shared Decision Making (SDM) Intervention for Oncologists: Web-based SDM Online Training and Individualized, Context-based Face-to-face SDM Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 4
- 主要终点
- Change from baseline in SDM competence measured by an objective Rating (OPTION)
研究概览
简要总结
Cancer patients often report that they are not included in important treatment decisions. Numerous studies have shown that a training concerning Shared Decision Making (SDM) for physicians can improve this situation. This does not only lead to a better quality of the doctor-patient interaction, but may have a positive long term impact on treatment adherence, the psychological well-being and the coping abilities of the patients. However, previous experience regarding the implementation of SDM training programs show that it is difficult to recruit physicians for an external SDM group training due to the extensive workload of the physicians. In light of the available evidence on the effectiveness of SDM training and the low motivation by oncologists for traditional SDM group training, this study aims to develop and evaluate a brief SDM intervention. This intervention is disseminated in two different ways which both might be attractive for oncologists. On the one hand an individual face-to-face context-based SDM training is designed and conducted by a trainer at the workplace of the participating oncologists. On the other hand a web-based SDM online training is developed. Both SDM interventions are developed on the basis of an SDM manual evaluated in previous studies.
This study therefore aims to examine the effectiveness of different disseminations strategies (individualized face-to-face context-based SDM individual training vs. web-based SDM online training) compared to a control group without any training. It will be analyzed which improvements in medical SDM competence can be accomplished by the different SDM trainings. Further the effects of the training on SDM knowledge, quality of the doctor-patient interaction and SDM self-efficacy expectation will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Oncologists or physicians treating a significant percentage of breast and/or colorectal cancer patients
- •Internet access
排除标准
- •No Exclusion Criteria
研究组 & 干预措施
SDM Online Training
The intervention consists of a SDM training for oncologists, which is conducted in the form of a web-based SDM online Training (intervention group I). During training, the oncologists are guided to use decision aids for breast and colon cancer patients in their consultations, which were developed and evaluated in a previous project. The SDM training has the same duration (one session à 120 minutes) in both intervention groups. Doctors in the intervention group receive decision aids for breast cancer and colorectal cancer patients during training. The training contents are based on an already developed, evaluated and published SDM manual. The SDM online training works on the modeling principle.
干预措施: SDM Training (Behavioral)
Face-to-Face SDM Training
The intervention consists of a SDM training for oncologists, which is conducted in the form of an individualized, context-based SDM individual face-to-face training at the workplace of the participants (intervention group II). During training, the oncologists are guided to use decision aids for breast and colon cancer patients in their consultations, which were developed and evaluated in a previous project. The SDM training has the same duration (one session à 120 minutes) in both intervention groups. Doctors in the intervention group receive decision aids for breast cancer and colorectal cancer patients during training. The training contents are based on an already developed, evaluated and published SDM manual. The individual training works on the coaching principle.
干预措施: SDM Training (Behavioral)
Control Group
The Control Group receives no SDM Training. All participants of the Control Group will be offered to participate in the SDM Online Training after T2.
结局指标
主要结局
Change from baseline in SDM competence measured by an objective Rating (OPTION)
时间窗: T0 (2 weeks before Training) and T1 (1 weeks after Training)
To measure the SDM competence the OPTION scale (Observing Patient Involvement; Elwyn et al., 2003; Elwyn et al., 2005; Goss et al., 2007.) will be used. The OPTION scale is a validated instrument for measuring the process steps of Shared Decision Making. The consultations are assessed on the basis of 12 items. It shows good reliability with a value of 0.79. The Option rating is based on video recordings and anonymised transcripts. A consultation will be assessed by two blinded raters. The average value per item is used as final value. For the consultations standardized patients are deployed.
次要结局
- Change from baseline in quality of doctor-patient-interaction by subjective Patient rating (Questionnaire on the Quality of physician-patient interaction)(T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1))
- Change from baseline in quality of doctor-patient-interaction by subjective Physician rating (Questionnaire on the Quality of physician-patient interaction)(T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1))
- Change from baseline in SDM competence by subjective standardized patient rating (Dyadic Option)(T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1))
- Change from baseline in SDM competence by subjective physician rating (Physician-Perception-Scale)(T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1))
- Change from baseline in SDM competence by subjective standardized patient rating (Patient Perception Scale)(T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1))
- Change from baseline in SDM competence by subjective standardized patient rating (SDM-Q-9)(T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1))
- Change from baseline in SDM competence by subjective physician rating (Dyadic Option)(T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1))
- Change from baseline in SDM competence by subjective physician rating (SDM-Q-9)(T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1))
研究者
Dr. Kathrin Gschwendtner
Prinicipal Investigator
University Hospital Heidelberg