A Hybrid Implementation-effectiveness Stepped Wedge Cluster Randomised Controlled Trial to Determine the Effectiveness of the Goals of Care Initiative
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Decision Conflict Scale
研究概览
简要总结
A single site hybrid implement-evaluation stepped wedge cluster randomised controlled trial in which cancer cluster groups (lung, colorectal, breast, renal, ovarian, upper GI & sarcoma) are randomised sequentially to initiate the Goals of Care Initiative into clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Undergoing, or being considered for, systemic treatment from one of the cluster teams.
- •18+ years.
- •Able to give written consent.
- •Able to understand verbal and written English.
排除标准
- •Patient is not being considered for Systemic Anti-Cancer Treatment.
结局指标
主要结局
Decision Conflict Scale
时间窗: Immediately following intervention
Patient satisfaction with decision and overall decision conflict will be measured using the Ottawa Decisional Conflict Scale. The scale consists of 16 items with patients scoring themselves on a five point scale (0, Strongly Agree - 4, Strongly Disagree). The scale includes five subscales: uncertainty, support, values, informed, effective decision. The total score and subscale scores are calculated by dividing the sum of the items by the number of items within that subscale and multiplying by twenty five (scored range from 0 to 100; 0 score indicates no decisional conflict, 100 indicates extremely high decisional conflict). This scale evaluates the quality of decision as outlined within internationally recognised guidelines to establish the effectiveness of decision aids. Furthermore, some of the subscales address evaluating the quality of the decision process (feeling informed about the options, clarity of values).
SDM-Q-9
时间窗: Immediately following intervention
Patient involvement in decision making will be measured using the SDM-Q-9 questionnaire. The questionnaire contains nine items with respondents scoring on a six point scale (0 represents completely disagree to 5 which represents completely disagree) how much they agree with the presented statement. The highest score attainable, 45, represents the highest level of perceived Shared Decision Making and 0 represents no perceived involvement in Shared Decision Making.
次要结局
- Decision Self Efficacy Scale(Immediately following intervention, then at 6 weeks and 12 weeks.)
- EQ-5D-5L(Immediately following intervention, then at 6 weeks and 12 weeks.)