Comparison of Explicit Values Clarification Method (VCM), Implicit VCM and no VCM Decision Aids for Men Considering Prostate Cancer Screening: Protocol of a Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 276
- 主要终点
- Perceived clarity of personal values
研究概览
简要总结
The investigators aim at comparing the perceived clarity of personal values in men considering PSA screening using decision aids with no VCM versus an implicit VCM versus an explicit VCM. This study will add to the body of evidence on the role of decision aids to support health preference-sensitive choices and provide further insight on the impact of different methods for eliciting people's values embedded within a decision aid.
详细描述
PSA test to screen for prostate cancer is considered a preference sensitive decision, meaning it does not only depend on what is best from a medical point of view, but also on patient values. Decision aids are evidence-based tools which showed to help people feel clearer about their values, therefore it has been advocated that decision aids should contain a specific values clarification method (VCM). VCM may be either implicit or explicit but the evidence concerning the best method is scarce. We aim at comparing the perceived clarity of personal values in men considering PSA screening using decision aids with no VCM versus an implicit VCM versus an explicit VCM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •adult men (50 - 69 years);
- •men with average risk for prostate cancer;
- •willing and able to provide written informed consent.
排除标准
- •unable to understand written Portuguese.
研究组 & 干预措施
decision aid with information only (control)
decision aid with information only, without values clarification method (VCM)
decision aid with implicit VCM
decision aid with information plus an implicit VCM
干预措施: Decision aid with implicit values clarification method (booklet or website) (Other)
decision aid with explicit VCM
decision aid with information plus an explicit VCM
干预措施: Decision aid with explicit values clarification method (booklet or website) (Other)
结局指标
主要结局
Perceived clarity of personal values
时间窗: immediately after the intervention
3-item subscale of the Decisional Conflict Scale. Items are given a score of 0 ("strongly agree") to 4 ("strongly disagree"). Items are: a) summed; b) divided 3; and c) multiplied by 25. Scores range from 0 \[feels extremely clear about personal values\] to 100 \[feels extremely unclear about personal values\].
次要结局
- % of patients who underwent PSA screening (questionnaire)(6 months after the intervention)
- Decisional Conflict(immediately after the intervention)
- % of patients with preference to undergo PSA screening (screening intention; questionnaire)(before and immediately after the intervention)