Evaluating a Decision Aid in Clinical Practice for Patients With Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Comprehensibility of the decision aid too
研究概览
简要总结
Patients diagnosed with localized prostate cancer may be eligible for different treatment options. MAASTRO Clinic (MAAStricht Radiation Oncology) developed a web-based decision aid tool for these patients. The goal of the tool is to help patients to understand the treatments, and empower the patients to participate in the decision making process. The aim of this study is threefold:
(A) user-testing and validation of the tool, by using a systematically development process compliant with the IPDAS (International Patients Decision Aids Standards) criteria (B) establish the impact of the tool on the decision making process; (C) identify barriers and facilitators for the implementation of shared decision making and the tool in clinical practice.
The study covers 3 phases:
- Development phase 1.1 Assess decisional needs of patients and clinicians. 1.2 Test patients' and clinicians' comprehensibility, acceptability and usability on the alpha-version of the tool. 1.3 Value clarification: Delphi study with former prostate cancer patients to determine the most important patient preferences and value clarification aspects the decision aid should include.
- Implementation phase: Develop an implementation and dissemination plan for shared decision-making which is based on the evaluation of barriers and facilitators for the use of patient decision aid tools in clinical practice.
- Evaluation phase: Establish the impact of on knowledge, decisional conflict and the shared decision-making process, as well as the extent to which clinicians involve patients in decision-making.
A mixed method will be used. It comprises structured interviews combined with think aloud and questionnaires with stakeholders involved in the whole process of development, implementation and evaluation (patients, urologists, radiotherapists, nurses, general practitioners, patient organizations, and insurance companies).
详细描述
Prostate cancer is the most common malignancy observed among men in industrialized countries, with 1.11 million new cases diagnosed in 2012 . For patients with localized prostate cancer, different treatment options are available; radical prostatectomy, external beam radiotherapy, interstitial radiotherapy also called Brachytherapy (early-stage disease), and 'active surveillance' (low risk patients). The optimal treatment for patients having localized prostate cancer is not unambiguously proven. Different treatment options cause different side effects that may impact the patients' health-related quality of life. The treatment of choice depends on preferences and personal values. In these preference-sensitive choices it is important to involve the patient in the decision-making process. In this process both the practitioner and the patient exchange information and collaborate in the decision, the physician knows more technical information about the disease, the treatment options and the side effects, the patient knows how the treatment options correspond with his lifestyle, values and preferences.
Patient Decision Aids (PDAs) are tools that can help patients to get involved in decision making by clarifying treatment options, outcomes, and personal values. In the development process of a decision aid it is mandatory to follow a systematic and iterative approach to: (a) understand patient's decisional needs; (b) create prototypical tools; (c) evaluate these prototypes with patients and clinicians, and (d) use these results to improve the tool.
Considering the International Patient Decision Aid Standards (http://ipdas.ohri.ca/), the investigators designed an initial prototype, called Treatmentchoice (http://www.treatmentchoice.info). These standards recommend assessing patients and doctors views in decisional needs, use this information to develop an alpha version of the PDA and validate the Treatmentchoice again with patients and doctors to create a beta version.
The aim of this project is user-testing the initial prototype of the Treatmentchoice. This will allow the investigators to follow a systematic development process and to gain knowledge on the validity of approach of the investigators. The project covers 4 activities:
ACTIVITY 1.1: ASSESS DECISIONAL NEEDS: Elicit patients' and clinicians' views on patient's information, expectations, and needs on decision support. Conclusions and recommendations for improvement of Treatmentchoice will be derived and the current prototype will be improved creating an alpha prototype.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with localized prostate cancer. There are no criteria for treatment type.
- •Inclusion criteria:
- •Stage I-II primary prostate cancer
- •Proficient in Dutch
- •> 18 years old
排除标准
- •Patients that do not have a treatment choice (due to contra-indications or other medical reasons)
- •Patients with recurrent disease.
- •For alpha testing patients that already made their decision are selected. For each treatment (external beam radiotherapy (RT), interstitial RT, surgery and active surveillance) at least 10 patients will be included.
- •For beta testing patients that are facing their decision will be included. Aiming for an effect size of 0.60 for a difference in mean total score on the Decisional Conflict Scale, it would require 45 patients per group (pre and post intervention) to determine this effect with alpha 0.05 and power 0.
- •For the Delphi study prostate cancer patients who already underwent treatment will be included.
- •Clinicians:
- •Radiotherapy-oncologists
- •Urologists
- •General practitioners
- •For alpha testing at least 10 physicians are selected.
- •For beta testing at least 45 questionnaires are required.
- •Patient organizations and insurance companies will be interviewed to evaluate barriers and facilitators for implementation in clinical practice. The study will focus on their respective roles in the promotion of shared decision making: patient organizations in raising awareness among patients and insurance companies in providing incentives for the use of decision aids in clinical practice.
结局指标
主要结局
Comprehensibility of the decision aid too
时间窗: up to 1 year
Quantitative research using the Unified Theory of Acceptance and Use of Technology (UTAUT Venkatesh et al. 2013). This questionnaire. (5-Likert) measure how patients and clinicians perceived its utility, effectiveness and efficiency for shared decision-making, as well as their satisfaction with the decision aid.
Decisional conflict (patients, evaluation phase)
时间窗: 2 weeks after diagnosis
Decisional conflict will be assessed using the DCS (Decisional conflict scale): change in DCS between baseline group (usual care) and intervention group (use of the aid tool)
Control Preference Scale (patients; evaluation phase)
时间窗: 2 weeks after diagnosis
Patient's preference to participate in medical decisions will be assessed using the 5-item Control Preference Scale (CPS):change in CPS between baseline group (usual care) and intervention group (use of the aid tool)
Perception shared decision-making (patients; evaluation phase)
时间窗: 2 weeks after diagnosis
Patient's perception of the shared decision-making process will be assessed using the (shared decision making) SDM-Q9 instrument for patients: change in SDM between baseline group (usual care) and the intervention group (use of the aid tool)
Perception shared decision-making (doctors; evaluation phase)
时间窗: 2 weeks after diagnosis
Doctor's perception of the shared decision-making process will be assessed using the SDM-Q9 instrument for professionals: change in SDM between baseline group (usual care) and the intervention group (use of the aid tool)\]\]
Usability of the decision aid too
时间窗: up to 1 year
Quantitative research using a questionnaire based on the International Standard ISO-9242-11. This questionnaire (5-Likert) measure to what extent the decision aid is easy to use.
Patient's decisional needs to make a decision about their treatment
时间窗: up to 1 year
Patients' decisional needs (development phase):semi-structured interviews with patients about their medical history, their experience with the treatment, the decision about their treatment, and what information the patients need to make an informed decision
次要结局
- Patients' intention to use and recommend Treatmentchoice to others(upto 1 year)
- Insights into the value clarification process of prostate cancer patients(an average of 2 year)
- Patients' satisfaction with decision aid (Treatmentchoice)(upto 1 year)
- Patients' views on the current decision-making process(upto 1 year)