Evaluation of a Program for Routine Implementation of Shared Decision-Making in Cancer Care: A Stepped Wedge Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,131
- 试验地点
- 3
- 主要终点
- Change in uptake of shared decision-making from the patients' perspective
研究概览
简要总结
This study aims to evaluate a theoretically and empirically grounded implementation program designed to foster shared decision-making in routine cancer care. The intervention program consists of several components (e.g. training for health care professionals, patient empowerment strategies) that will be rolled out in three clinics at a comprehensive cancer center in Germany.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 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
- 否
入选标准
- •for participating patients:
- •diagnosed with neoplasms (ICD 10: C00-D49, excluding D10-D36)
- •admitted for inpatient or outpatient treatment at the participating clinics
- •age > 18 years
- •German-speaking
排除标准
- •for participating patients:
- •severe cognitive impairment
- •Inclusion Criteria for participating health care professionals:
- •physician or nurse working at the participating clinics
- •Exclusion Criteria for participating health care professionals:
研究组 & 干预措施
Shared decision-making program
干预措施: Shared decision-making program (Other)
Usual care
干预措施: Usual Care (Other)
结局指标
主要结局
Change in uptake of shared decision-making from the patients' perspective
时间窗: All clinics: baseline, 8 months, 16 months, 24 months
Action to employ shared decision-making as measured by the German version of the 9-item Shared Decision Making Questionnaire (SDM-Q-9)
次要结局
- Change in penetration of shared decision-making at the clinic level(baseline, 3 years)
- Acceptability of shared decision-making from the health care providers' perspective(All clinics: baseline, 8 months, 16 months, 24 months)
- Change in penetration of shared decision-making in multidisciplinary team meetings(All clinics: baseline, 8 months, 16 months, 24 months)
- Readiness for implementing change from the health care professionals' perspective(All clinics: baseline, 8 months, 16 months, 24 months)
- Appropriateness of shared decision-making from the health care professionals' perspective(All clinics: baseline, 8 months, 16 months, 24 months)
- Change in uptake of shared decision-making from external observers' perspective(All clinics: baseline, 8 months, 16 months, 24 months)
研究者
Isabelle Scholl
Head of Research Group, Prinicipal Investigator
Universitätsklinikum Hamburg-Eppendorf