Promoting Shared-decision Making in Opportunistic Screening for Prostate Cancer (PROSHADE)
調査の概要
詳細な説明
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.
Finally, the investigators will carry out a cluster randomised controlled trial, to assess the results derived from the application of the decision-aid, together with a process evaluation using a combination of both qualitative and quantitative methods to monitor the fidelity of the intervention, the clusters' and patients' response to the intervention as well as the mechanisms of adaptation and change at the intervention.
研究の種類
入学 (予想される)
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Group 1 (patients): Men living in the Valencian Community, Spain. Group 2 (general practitioners): Primary care doctors working in the Valencian Community, Spain.
Group 3 (urologists): Urologists working in the Valencian Community, Spain.
説明
Inclusion Criteria:
Patients:
- 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.
Exclusion Criteria:
- Patients: None
- General practitioners: None
- Urologists: None
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:他の
- 時間の展望:断面図
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Patients
Quantitative study: Surveys: 1,067 out of a total of 1,389,725 people of residents of the Valencian Community, Spain. Three groups with quota control: proportional to age (40-50; 50-70; > 70 years) of men aged 40 and over who have not had prostate cancer from each stratum (geographical area and population habitat). Qualitative study: general population focus groups: 3 |
Quantitative survey (cross-sectional design) and qualitative analysis (focus groups)
|
|
General Practitioners
Quantitative study: 369 General Practitioners working in two Health Departments in the Valencian Community, Spain (Dept of Health Alicante, General Hospital 19, 255,439 habitants) and (Dept of Health Alicante, S Juan Alicante 17, 233,115 habitants). Qualitative study: general practitioners focus groups: 2. |
Quantitative survey (cross-sectional design) and qualitative analysis (focus groups)
|
|
Urologists
Quantitative study: 345 Urologists working in Valencian Community, Spain Qualitative study: urologists focus groups: 1.
|
Quantitative survey (cross-sectional design) and qualitative analysis (focus groups)
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patients' and clinicians' knowledge on PSA test questionnaire developed by the investigators
時間枠: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.
|
December 2022
|
|
Patients' and clinicians' opinions on PSA test
時間枠: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.
|
March 2023
|
|
Number of patients who participated in a shared-decision making with their clinicians when receiving a PSA test
時間枠: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.
|
December 2023
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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