Creation of a Shared Medical Decision-making Tool for Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Creation of a shared medical decision-making tool in the context of a consultation for atopic dermatitis in a specialized dermatology consultation.
研究概览
简要总结
Hypothesis/Objective : Patient-centered health care and shared decision making are key components of increasing importance which are recommended by the French Haute Autorite de Sante (HAS) and World Health Organization (WHO).
In the context of dermatology and atopic dermatitis, European guidelines has promoted an active involvement from both patients and caregivers in therapeutic decisions at all stages to achieve therapeutic success and the Task Force on Atopic Dermatitis (ETFAD) has promoted the setting of treatment goals in a shared decision with the patient.
The main objective of this study is to develop and cross culturally validate a tool dedicated to shared-decision in atopic dermatitis that can be used during routine dermatological consultations.
The second objective is to better characterize patients seen in this context and to evaluate patients' satisfaction when empowered by shared decision.
Method : We aim to develop a SDMt in AD following the recommendations of the International Patient Decision Aid Standards (IPDAS) collaboration. Development will use a multistep approach: 1) identification of priority domains for patients; 2) Selection of domains to be included in the SDMt for AD; and 3) Creation and testing of the SDMt.
Participants will be consecutive adult (>18 years old) patients attending consultation for a AD in medical centres in France (Toulouse, Nantes and Créteil). All participants will provide written consent to participate. The study will be submitted for approbation to the local ethics committees of the University Hospital Centres of Paris and will be conducted according to the Declaration of Helsinki.
Step 1: Identification of priority domains for patients
Step 2: Selection of domains to be included in the SDMt for AD
Step 3: Creation and testing of the SDMt
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years, male or female.
- •Patient with atopic dermatitis
- •Written information given to the patient and no objection from the patient to participate to the study
排除标准
- •Patient under guardianship or curatorship
- •Patient with cognitive dysfunction that makes it impossible to communicate effectively or to complete the questionnaire
- •Patient under AME
结局指标
主要结局
Creation of a shared medical decision-making tool in the context of a consultation for atopic dermatitis in a specialized dermatology consultation.
时间窗: through study completion, an average of 1 year
Qualitative descriptions of the topics discussed by the patient during the therapeutic decision in a specialized dermatology consultation for atopic dermatitis; in other words, to characterize the topics discussed by the patient during the consultation
次要结局
- Patient satisfaction with the therapeutic decision-making process(during the intervention)
- Assessment of the perceived state of the patient about the intervention(during the intervention)
- Assessment of the psychological state of the patient(during the intervention)
- Description of treatment compliance in patients who received the validated tool(during the intervention)
- Assessment of the perceived health state of the patient(during the intervention)
- Assessment of the quality of life of the patient(during the intervention)
- Assessment of the stigmatization perceived by the patient(during the intervention)
- Assessment of the severity perceived by the patient(during the intervention)