Effectiveness of a Decision Aid for Patients With Knee Osteoarthritis Candidates for Primary Total Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 193
- 试验地点
- 1
- 主要终点
- Decisional conflict, measured by the Decisional Conflict Scale (DCS).
研究概览
简要总结
The main goal of this study is assess the effectiveness of a DA for patients with knee osteoarthritis candidates to ART
详细描述
The number of knee total arthroplasty (ART) interventions has increased in the last 10 years in European countries, partly due to the aging of the population and partly because of the increase in the use of these interventions to improve the quality of life among elderly patients. According to the Organization for Economic Cooperation and Development (OECD) 2012, from 2000 to 2010 in Spain the percentage of knee ART has doubled in recent years. .
The role of citizens in decisions affecting their health is changing. Individual factors such as improving educational attainment and access to medical information, and collective factors such as training of patient groups and changes in legislation (informed consent, autonomy principle) have motivated the transition from a paternalistic model to a co-responsibility model. Shared decision-making (TDC) has been proposed in recent years as a model of care that promotes users' involvement in the decisions about their treatment, in those situations where there is uncertainty and / or the scientific evidence reports a balance between benefits and risks that is similar for two or more therapeutic options. Decision aids (DA) are tools designed to promote and facilitate patients' involvement in medical decisions concerning their health
Objectives:
To assess the effectiveness of a DA for patients with knee osteoarthritis candidates to ART
Methodology:
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
盲法说明
Open label
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with osteoarthritis of the knee
- •Candidates for arthroplasty
排除标准
- •Patients who have already undergone knee arthroplasty
- •Patients younger than 18 years
研究组 & 干预措施
Control group
In the control group, the usual explanation about the disease and the possibilities of treatment will be followed
Intervention group
In the Intervention group, the Decision Aid (DA) will be presented and explained to the patient by research personnel at a schedule previously agreed with the patient. The patient will be given a paper copy of the (DA) to take home, as well as a web link to the computer application, and oral and written instructions to review the material again and perform value clarification exercises.
干预措施: Decision aid (Other)
结局指标
主要结局
Decisional conflict, measured by the Decisional Conflict Scale (DCS).
时间窗: Immediately after the intervention; 6 months after the intervention (only non-operated patients)
The DCS measures patients' uncertainty about treatment choice. It is composed of five subscales: uninformed, values, support, uncertainty and effectiveness
次要结局
- Knowledge of the disease and treatments(Immediately after the intervention; 6 months after the intervention (only non-operated patients))
- Goals and concerns(Immediately after the intervention; 6 months after the intervention (only non-operated patients))
- Treatment preference(Immediately after the intervention; 6 months (only non-operated patients))
- Satisfaction with the decision making process(Immediately after the intervention; 6 months)
- Decisional regret, measured by the Decisional Regret Scale (DRS)(6 months (only operated patients))