Santeon Hospital Group, Utrecht, The Netherlands
Santeon Hospital Group, Utrecht, The Netherlands.
BMJ Open. 2022 Aug 1;12(8):e055324. doi: 10.1136/bmjopen-2021-055324.
Within the value-based healthcare framework, outcome data can be used to inform patients about (treatment) options, and empower them to make shared decisions with their health care professional. To facilitate shared decision-making (SDM) supported by outcome data, a multicomponent intervention has been designed, including patient decision aids on the organisation of post-treatment surveillance (breast cancer); discharge location (stroke) and treatment modality (advanced kidney disease), and training on SDM for health care professionals. The SHared decision-making supported by OUTcome information (SHOUT) study will examine the effectiveness of the intervention and its implementation in clinical practice.
Multiple interrupted time series will be used to stepwise implement the intervention. Patients diagnosed with either breast cancer (N=630), stroke (N=630) or advanced kidney disease (N=473) will be included. Measurements will be performed at baseline, three (stroke), six and twelve (breast cancer and advanced kidney disease) months. Trends on outcomes will be measured over a period of 20 months. The primary outcome will be patients' perceived level of involvement in decision-making. Secondary outcomes regarding effectiveness will include patient-reported SDM, decisional conflict, role in decision-making, knowledge, quality of life, preferred and chosen care, satisfaction with the intervention, healthcare utilisation and health outcomes. Outcomes regarding implementation will include the implementation rate and a questionnaire on the health care professionals' perspective on the implementation process.
The Medical research Ethics Committees United in Nieuwegein, the Netherlands, has confirmed that the Medical Research Involving Human Subjects Act does not apply to this study. Bureau Onderzoek & Innovatie of Santeon, the Netherlands, approved this study. The results will contribute to insight in and knowledge on the use of outcome data for SDM, and can stimulate sustainable implementation of SDM.
NL8374, NL8375 and NL8376.
在基于价值的医疗保健框架内，结果数据可用于向患者提供（治疗）选择信息，并使他们能够与医疗保健专业人员共同做出决策。为了促进基于结果数据的共同决策（SDM），设计了一项多组分干预措施，包括关于治疗后监测（乳腺癌）、出院地点（中风）和治疗方式（晚期肾病）的组织的患者决策辅助工具，以及对医疗保健专业人员进行 SDM 的培训。SHared decision-making supported by OUTcome information (SHOUT) 研究将检验该干预措施及其在临床实践中的实施效果。
将使用多个中断时间序列逐步实施干预措施。将纳入诊断为乳腺癌（N=630）、中风（N=630）或晚期肾病（N=473）的患者。将在基线、三个月（中风）、六个月和十二个月（乳腺癌和晚期肾病）时进行测量。将在 20 个月的时间内测量结果趋势。主要结局是患者对决策参与度的感知程度。关于效果的次要结局包括患者报告的 SDM、决策冲突、决策中的角色、知识、生活质量、偏好和选择的护理、对干预的满意度、医疗保健利用和健康结果。关于实施的结局包括实施率和一份关于医疗保健专业人员对实施过程看法的问卷。
荷兰乌得勒支联合医学伦理委员会已确认，本研究不适用《涉及人体医学研究的医疗研究伦理法》。荷兰的 Bureau Onderzoek & Innovatie of Santeon 批准了这项研究。研究结果将有助于深入了解和掌握基于结果数据的 SDM 应用，并能够促进 SDM 的可持续实施。
NL8374、NL8375 和 NL8376。
