Impact of a Patient Decision Aid Intervention for Cancer Patients. Does Timing and Format Matter?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- Level of involvement of patients in shared decision making (breast cancer)
研究概览
简要总结
Studies evaluating decisions aids have used a wide range of outcome measures as well as formats and settings. Most studies have focused on patient decision aids used either within the consultation or delivered pre-consultation, but there are no randomised, controlled studies comparing the two. However, timing and format of the patient decision aid intervention may affect how useful the tool is to the patient. The aim of this project is therefore to deepen our understanding of the patient's engagement in and preparation for the decision making process in a randomised, controlled trial comparing an electronic pre-consultation and paper-based in-consultation patient decision aid. 274 patients with colorectal and breast cancer are enrolled in the study. Data are collected at both patient and consultant perceived levels as well as an observed level of shared decision making.
详细描述
A cancer diagnosis is life-changing and followed by complex decisions about treatment options. Often the decision about which treatment to choose is based on risks and benefits, although the benefit-harm ratios are unknown. In these situations, a patient decision aid can be helpful in explaining the options, clarifying the patient's preferences and acting as an adjunct to the clinician's counselling, supporting the patient in complex decisions about their diagnosis.
Studies evaluating patient decision aids have used a wide range of outcome measures as well as formats and settings. Most studies have focused on patient decision aids used either within the consultation or delivered pre-consultation, but there are no randomised, controlled studies comparing the two. There is a lack of evidence of the impact of patient decison aids used pre-consultation versus in-consultation, as timing and format of the patient decision aid intervention may affect how useful the tool is to the patient. The aim of this project is therefore to deepen our understanding of the patient's engagement in and preparation for the decision making process in a randomised, controlled trial comparing a digital pre-consultation and paper-based in-consultation patient decision aid. 274 patients with colorectal and breast cancer are enrolled in the study. Data are collected at both patient and consultant perceived level as well as an observed level of shared decision making (SDM).
A secondary analysis of the data collected in the study will form the basis of a study testing the convergent validity of the patient-reported measures by comparing them to the observed level of patient involvement. During the last decade, the strong move towards increased SDM has led to development of several measurement scales, and there is a demand for convergent validity studies, as there is no gold standard to evaluate SDM behaviors. Previous validity studies have various shortcomings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically verified breast or colorectal cancer
- •Age ≥ 18 years
排除标准
- •Unable to read Danish
- •Not the owner/user of a mobile smartphone
结局指标
主要结局
Level of involvement of patients in shared decision making (breast cancer)
时间窗: Within one week after the consultation
4-item Shared Decision Making Process Scale (SDM Process 4) with patient-reported measures of the amount of shared decision making that occurs around the medical decision. Score range is 0 to 4 points, a higher score indicates more involvement in the decision.
Observed level of patient involvement in decision making according to the OPTION5 tool (colorectal cancer)
时间窗: Through study completion, an average of 3 months
settings (OPTION5). Scores range 0-100. Higher score indicates higher patient involvement in decision making.
次要结局
- Level of patient preparation for decision making (breast and colorectal cancer)(Within one week after the consultation)
- Level of involvement of patients in shared decision making (colorectal cancer)(Within one week after the consultation)
- Patient-perceived level of shared decision making (breast and colorectal cancer)(Within one week after the consultation)
- Degree of control over the decision about medical treatment (breast and colorectal cancer)(Before the consultation)
- Consultant-perceived level of shared decision making (breast and colorectal cancer)(Within one week after the consultation)
- Level of decisional conflict (breast and colorectal cancer)(Before consultation and within one week after the consultation)
- Patient-perceived level of shared decision making between patient and consultant (breast and colorectal cancer)(Within one week after the consultation)
- Observed level of patient involvement in decision making according to the OPTION5 tool (breast cancer)(Through study completion, an average of 3 months)