Promoting Shared-decision Making in Opportunistic Screening for Prostate Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 1,781
- 主要终点
- Number of patients who participated in a shared-decision making with their clinicians when receiving a PSA test
研究概览
简要总结
In this project, the investigators aim to evaluate the most appropriate design and implementation strategy of a decision-aid to promote shared-decision making in prostate cancer screening.
详细描述
Prostate cancer (PC) screening using Prostate Specific Antigen (PSA) has led to a reduction in advanced disease and disease-specific mortality. However, screening with PSA can also cause harm and is associated with false-positive results and overdiagnosis.
Shared-decision making (SDM) has been defined as the key to successful patient-centered care. The promotion SDM when deciding on PSA screening will have proximal effects such as the development of collaborative deliberation between clinicians and patients, resulting in well-informed patients and in preference-based decisions. As long term effects, it will result in safer, cost-effective, patient-aligned healthcare, and its distant effects will include improvements in resource use, planning processes and improved health outcomes.
The project includes a mixed-method approach. The investigators will perform a quantitative survey (cross-sectional design) to evaluate the population, patients' and clinicians' knowledge about the benefits and risks derived from the PSA determination and the available recommendations.
The investigators will apply qualitative analysis through focus groups, to explore the challenges patients and clinicians face to deep in a prostate screening discussion and to assess the adequacy of different implementation strategies.
The investigators will carry out a user-testing design based on mix-methods (questionnaire and semi-structured review) to evaluate the prototype of the initial decision-aid.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men >40 years old
- •Men who have not had prostate cancer
- •General practitioners:
- •Primary care doctors working in the Valencian Community, Spain.
- •Urologists:
- •Urologists working in the Valencian Community, Spain.
排除标准
- •Patients: None
- •General practitioners: None
- •Urologists: None
结局指标
主要结局
Number of patients who participated in a shared-decision making with their clinicians when receiving a PSA test
时间窗: December 2023
The investigators will assess the number of patients who participate in a shared- decision making with their clinicians when receiving a PSA test. To assess it, the investigators, through a randomized clinical trial, will apply a new decision-aid developed to a group of patients which will be compared with another group which will have normal care.
Patients' and clinicians' knowledge on PSA test questionnaire developed by the investigators
时间窗: December 2022
Quantitative questionnaire to evaluate the target population and clinicians' knowledge about the PSA benefits/risks and the available recommendations. The investigators will develop an ad hoc questionnaire which will be validated through the Delphi Method.
Patients' and clinicians' opinions on PSA test
时间窗: March 2023
Focus groups to explore qualitatively the challenge patients and clinicians face when discussing prostate cancer screening and to assess their preferences about different designs and implementation strategies.
次要结局
未报告次要终点
研究者
Blanca Juana Lumbreras Lacarra
Professor
Universidad Miguel Hernandez de Elche